Post-surgical Functional Results in Patients With Epiretinal Membrane Undergoing Controlled Macular Detachment: Pilot Study.
Phase: NA
Conditions: Epiretinal Membrane Surgery
Sponsor: Asociación para Evitar la Ceguera en México

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
 
RESEARCH PROTOCOL 
  
1.  GENERAL DATA 
  
1.1.     Title: “Post-surgical functional results “in patients with 
epiretinal 
membrane 
undergoing 
controlled 
macular 
detachment: Pilot Study.” 
  
1.2.     Area of study: Surgical treatment of grade III and IV 
epiretinal membranes 
  
1.3.     Probable Start Date: March 1, 2025 
Probable completion date of the study: February 23, 2026 
  
1.4.     Lead author: Raúl Vélez Montoya. MD. Ophthalmologist. 
Retina Specialist  
  
1.5.     Co-researchers: 
Dr. Oriana Gómez Erazo 
Dr. Karla Paola García 
Dr. Gisel Vigueras 
  
1.6.     Head of Service Responsible for Protocol: Dr. Jorge 
Jans Fromow Guerra. Chef of the Retina Service. 
  
1.7.     Participating institutions: APEC. 
  
  
2.  THEORETICAL FRAMEWORK 
 
2.1.     Project Summary 
This study aims to evaluate postsurgical functional changes in patients with 
advanced epiretinal membrane (ERM) (stages 3 and 4) by integrating controlled 
macular detachment with balanced salt solution into the conventional ERM 
peeling technique. Visual acuity evolution will be analyzed using the ETDRS letter 
scale. At the same time, anatomical and microvascular changes will be assessed 
by optical coherence tomography (OCT) and optical coherence tomography 
angiography (OCT-A) to evaluate their impact on visual recovery. This technique 
is expected to minimize persistent distortion, promote restoration of retinal 
perfusion, mitigate postoperative ischemia, and improve macular structural 
stability, potentially leading to more significant functional recovery. It is designed 
as a prospective longitudinal pilot study; The research will be conducted in the 

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Retina Department of the Association to Prevent Blindness in Mexico (APEC), 
focusing on patients over 18 years of age diagnosed with advanced MRD and 
eligible for vitreoretinal surgery. 
 
2.2.     Background 
Epiretinal membrane (ERM) is a fibrocellular formation on the inner surface of the 
macula. A common pathology in older people that causes visual impairment and 
metamorphopsia. [1] Several risk factors have been identified, including age (the 
most important), race, sex, smoking, diabetes, peripheral arterial disease, and 
hypercholesterolemia. [2] 
Epiretinal membrane (ERM) can be idiopathic or secondary to other retinal 
pathologies. Although the exact etiology of idiopathic forms is unknown, several 
theories have been proposed. The first theory suggests that a posterior vitreous 
detachment (PVD) can cause tears in the internal limiting membrane (ILM), 
facilitating the migration of myofibroblastic cells along with extracellular matrix 
components [3,4]. Another theory suggests that an anomalous PVD with 
vitreoschisis leaves cortical remnants of the vitreous in the premacular region, 
which induces the production of cytokines, such as fibroblast growth factor and 
nerve growth factor, thus stimulating cell proliferation [5,6,7]. 
Recently, it has been studied that the deeper the foveal microstructure, the more 
likely it is to identify anatomical changes that may be related to poor final visual 
acuity and poor postoperative recovery. [8] In 2017, Govetto et al. proposed a 
new staging based on SD-OCT findings. He suggests the division into 4 stages: 
Stage 1 mild ERM with minimal anatomical changes, Stage 2 loss of foveal 
depression associated with more anatomical changes but the retinal layers are 
well distinguished, Stage 3 internal foveal ectopic layers but good definition of the 
retinal layers, Stage 4 advanced ERM with total loss of foveal architecture. [9] 
Early ERM grades are associated with better postoperative visual outcomes and 
exhibit fewer changes in the epithelial-mesenchymal transition. In grades 3 and 
4, the presence of ectopic foveal inner layers suggests abnormal retinal 
reorganization, which significantly alters foveal structure and limits functional 
recovery. These findings underscore the importance of early intervention. [10,11] 
Saline-controlled macular detachment is an innovative surgical technique that 
involves the intraoperative administration of a balanced salt solution into the 
subretinal space, creating a temporary, controlled macular detachment. Its 
primary objectives are to reduce mechanical traction, facilitate retinal 
reattachment and alignment, and improve surgical outcomes by minimizing the 
risk of persistent distortion, thereby promoting visual recovery. Furthermore, 
controlled macular detachment enables retinal expansion and repositioning, 

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thereby improving structural stabilization. Furthermore, by reducing retinal 
stiffness, it aids photoreceptor realignment and prevents persistent macular 
shrinkage, leading to optimization of postoperative retinal architecture and 
functional recovery. These qualities would be highly appreciated in cases of 
epiretinal membrane (ERM) with significant inner retinal distortion (stages III and 
IV). [11,12] Another key mechanism involves the modulation of retinal adhesion 
and fluid dynamics to facilitate complete ERM clearance and macular recovery. 
Szurman et al. (2006) demonstrated that modifying retinal adhesiveness with 
saline reduces cellular damage during artificial retinal detachment, preserving 
photoreceptor integrity and improving postoperative outcomes. [13] 
Optical coherence tomography angiography (OCT-A) reveals key postoperative 
changes that are essential for assessing outcomes in macular detachment with 
controlled macular detachment. A key finding is the progressive increase in 
vascular density (VD) in the superficial and deep plexus with time after macular 
detachment, which correlates with macular microvascular restoration and 
improved perfusion [14]. The widening of the foveal avascular zone (FAZ), often 
linked to ischemic stress, and the gradual reduction in central macular thickness 
(CMT) reflect the release of retinal traction and structural reorganization [15,16]. 
Centrifugal macular shift is another significant postoperative effect of FAZ 
widening and inner retinal thinning [17]. Modulation of retinal adhesion through 
calcium depletion and temperature adjustments minimizes damage, preserving 
photoreceptors and improving recovery [18]. Furthermore, saline-assisted 
detachment and reattachment can reduce ischemia and improve perfusion, while 
planned foveal detachment has shown benefits in reducing retinal thickness and 
improving visual outcomes by regulating subretinal fluid dynamics and preserving 
vascular integrity [19]. 
23.     
Justification 
Advanced epiretinal membrane (ERM) (grades 3 and 4) causes significant 
alteration of the macular architecture, leading to a poor visual prognosis. 
Tangential shrinkage, damage to the inner retinal layers, and disorganization of 
the outer layers limit visual recovery even after surgery using conventional 
techniques. 
Currently, vitrectomy with internal limiting membrane peeling is the standard 
procedure; however, its ability to improve visual acuity in these patients remains 
limited. In this context, controlled macular detachment emerges as a surgical 
alternative that could optimize the anatomical and functional restoration of the 
retina. By more effectively correcting structural alterations of the macula, this 
technique could translate into better postoperative visual recovery. 
  
2.4.     Problem statement 

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Although vitrectomy with internal limiting membrane detachment is the standard 
treatment, this technique does not always achieve significant visual improvement, 
especially in cases of advanced ERM, where structural damage is more 
pronounced. 
Given this situation, controlled macular detachment (CMD) emerges as an 
alternative technique that could offer a way to improve the anatomical and 
functional restoration of the retina. However, it remains to be seen whether its 
incorporation into conventional techniques results in significant visual benefits. 
Therefore, the central purpose of this investigation is to evaluate whether the 
combination of controlled macular detachment with the standard surgical 
technique significantly improves visual acuity in patients with advanced ERM, 
compared with the conventional technique alone. 
 
2.5.     Objectives and hypotheses 
2.5.1.   Objetives 
2.5.1.1.    General Objectives 
To evaluate whether the incorporation of controlled macular detachment to the 
conventional ERM peeling technique improves visual outcomes in patients with 
grade III and IV epiretinal membranes. 
 
2.5.1.2.    Specific Objectives 
- 
To describe the post-surgical anatomical changes of the macula using 
Optical Coherence Tomography (OCT). 
o Central macular thickness (µm). 
o Thickness of the inner nuclear layer (µm). 
o Ellipsoid zone disruption 
- 
To describe the postoperative vascular changes of the macula using 
optical coherence angiography (OCT-A). 
o Vascular density RV in superficial and deep plexus (%) 
o FAZ Foveal Avascular Zone (mm2) 
o Retinal thickness maps: central zone (1 mm), middle zone (3 mm) 
and external zone (6 mm). 
- 
Describe the overall safety level of the surgical technique  
 
2.5.2.   Hypothesis 
2.5.2.1.    General Hypothesis 
“The addition of controlled macular detachment to the conventional surgical 
technique significantly improves visual acuity compared with the standard 
technique, with an increase of at least 10 letters on the ETDRS scale at 3 months 
postoperatively in patients with grades 3 and 4 epiretinal membranes.” 
 
Ho: The incorporation of controlled macular detachment into the 
conventional surgical technique significantly improves visual acuity 

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compared to the standard technique, with an increase of at least 10 letters 
on the ETDRS scale at 3 months postoperatively, in patients with grade 3 
and 4 epiretinal membranes.” 
 
H1: The incorporation of controlled macular detachment into the 
conventional surgical technique significantly improves visual acuity 
compared to the standard technique, with an increase of at least 10 letters 
on the ETDRS scale at 3 months postoperatively, in patients with grade 3 
and 4 epiretinal membranes.” 
  
3.  STUDY DESIGN 
Prospective, Longitudinal, Experimental, Descriptive Cohort Study. 
  
4.  METHODOLOGY 
4.1.     Location and duration: Association to Prevent Blindness in 
Mexico, IAP Retina Department. 
Probable Start Date: March 1, 2025 
Probable completion date of the study: February 23, 2026 
  
4.2.     Population. 
4.2.1.   Observation unit. Analysis of the main outcome variable: 
Visual acuity measured in letters on the ETDRS scale. 
4.2.2.   Universe. Patients aged 18 years or older with a clinical 
diagnosis of grade 3 or 4 epiretinal membranes, as 
determined by Optical Coherence Tomography, who attend 
the Retina Department. 
4.2.3.   Sampling method: Non-probability by Convenience 
4.2.4.   Population acquisition. Recruitment of patients who are 
evaluated in the Retina Service and meet the inclusion 
criteria and sign the informed consent form. 
  
4.3.     Inclusion Criteria. 
- 
Patients over 18 years of age. 
- 
Patients with a confirmed diagnosis of ERM grade III or IV by 
Optical 
Coherence 
Tomography 
who 
present 
visual 
disturbances such as metamorphopsia or visual deterioration 
(measured in letters on the ETDRS scale) but who do not reflect 
terminal visual deterioration. 
- 
Patients suitable for vitreoretinal surgical procedures, with no 
uncontrolled medical comorbidities that contraindicate surgery, 
and who have an adequate support network. 

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- 
Patients who understand the objectives and risks of the study, 
and sign an informed consent. 
  
4.4.     Exclusion Criteria 
- Patients with a confirmed diagnosis of grade III or IV ERM by 
Optical Coherence Tomography who do not have the ability 
to improve their visual acuity. 
- Patients diagnosed with ocular pathologies that significantly affect 
their visual acuity, such as moderate or advanced glaucoma, 
non-glaucomatous optic neuropathies, or optic media 
opacities such as leukomas, significant corneal edema, or 
other maculopathies such as macular atrophy or macular 
ischemia. 
4.5.     DEFINITION OF VARIABLES 
  
Variable Name 
Operational 
Definition 
Nature and 
level of 
measuremen
t 
Unit of 
measuremen
t 
Measuring 
instrument 
Measuremen
t Time 
Age 
Time elapsed in 
years since the 
birth 
of 
an 
individual 
Independent 
Quantitative 
Discreet 
Reason 
Years 
completed 
Interrogation 
Visit 1. 
Pre-surgical 
Sex 
Phenotypic 
characteristic 
Independent 
Qualitative 
Nominal 
Man:0 
Woman: 1 
Interrogation 
Visit 1. 
Pre-surgical 
Place of birth 
City 
or 
Municipality 
of 
birth 
of 
the 
individual 
surveyed 
Independent 
Qualitative 
Nominal 
Different cities 
and 
municipalities 
in Mexico or 
abroad 
Interrogation 
Visit 1. 
Pre-surgical 
Place 
of 
Residence 
City 
or 
Municipality 
of 
residence 
Independent 
Qualitative 
Nominal 
Different cities 
and 
municipalities 
in Mexico or 
abroad 
Interrogation 
Visit 1. 
Pre-surgical 
Smoking status 
History 
of 
tobacco use: 
Independent 
Qualitative 
Never smoker: 
0 
Interrogation 
Visit 1. 
Pre-surgical 

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1. 
Never 
smoker: 
Participants 
who 
declared 
that they had 
never smoked in 
their life. 
2. 
Ex-smoker: 
Participants 
who 
reported 
having smoked 
previously 
but 
quit before the 
date 
of 
the 
study. 
3. 
Active 
smoker: 
Participants 
who 
reported 
using tobacco at 
the time of the 
study. 
Nominal 
Ex-smoker: 1 
Active 
smoker:2 
Diagnosis 
of 
hypertension 
Previous 
diagnosis 
of 
hypertension or 
current use of 
antihypertensiv
e medications 
Independent 
Qualitative 
Nominal 
Yes: 0 
No: 1 
Interrogation 
Visit 1. 
Pre-surgical 
Diagnosis 
of 
T2DM 
Previous 
diagnosis 
of 
T2DM or current 
use of glycemic 
control 
medications 
Independent 
Qualitative 
Nominal 
Yes: 0 
No: 1 
Interrogation 
Visit 1. 
Pre-surgical 
Visual Acuity 
Ability 
to 
discriminate fine 
details 
at 
a 
standard 
distance, 
assessed 
by 
reading 
letters 
on an ETDRS 
chart. 
Dependent 
Quantitative 
Discreet 
Number 
of 
letters 
correctly 
recognized (0 
to 100). 
ETDRS 
Chart 
Visit 1. 
Pre-surgical 
Visit 2. Day 4. 
Visit 3. Day 
30. 
Visit 4. Day 
90. 

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Metamorphopsia
s 
Disturbance 
in 
visual 
perception 
characterized 
by distortion in 
the 
shape 
or 
size of objects, 
especially 
straight 
lines 
that may appear 
wavy or curved 
Dependent 
Qualitative 
Nominal 
  
Yes: 0 
No: 1 
Amsler grid 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Metamorphopsia 
Quantification 
Disturbance 
in 
visual 
perception 
characterized 
by distortion in 
the 
shape 
or 
size of objects, 
especially 
straight 
lines 
that may appear 
wavy or curved 
Dependent 
Quantitative 
Continued 
Degrees? 
M - Charts 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Intraocular 
Pressure 
Measurement of 
the 
pressure 
exerted by the 
aqueous humor 
within 
the 
anterior 
chamber of the 
eye. 
Dependent 
Quantitative 
Continued 
  
Millimeters of 
mercury 
(mmHg). 
 
Digital 
Tonometer 
(ICare) 
Visit 1. 
Pre-surgical 
Visit 2. Day 4. 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Central 
macular 
thickness 
Average 
distance 
measured 
between 
the 
inner surface of 
the 
retina 
(internal limiting 
membrane) and 
the 
outer 
surface (retinal 
pigment 
epithelium 
or 
Bruch's 
membrane) 
in 
the central area 
of the macula 
Independent 
Quantitative 
Continued 
Micrometers 
(µm). 
Optical 
Coherence 
Tomography 
of the macula 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 

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measured 
through images 
obtained 
by 
OCT 
Thickness of the 
inner 
nuclear 
layer 
Quantitative 
measurement of 
the 
distance 
from the inner to 
the 
outer 
boundary of the 
inner 
nuclear 
layer measured 
through images 
obtained 
by 
OCT 
Independent 
Quantitative 
Continued 
Micrometers 
(µm). 
Optical 
Coherence 
Tomography 
of the macula 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Ellipsoid 
zone 
disruption 
Interruption 
or 
alteration of the 
line 
corresponding 
to the internal 
segments of the 
photoreceptors 
Independent 
Qualitative 
Nominal 
Absent: 0 
Present: 1 
Optical 
Coherence 
Tomography 
of the macula 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Vascular density 
RV in superficial 
plexus (%) 
Percentage 
of 
area 
occupied 
by blood vessels 
within 
the 
superficial 
capillary plexus 
of 
the 
retina, 
assessed using 
images 
obtained 
by 
OCTA. 
Independent 
Quantitative 
Continued 
Percentage 
(%) 
OCT - A 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
RV 
Vascular 
Density in plex or 
deep (%) 
Percentage 
of 
area 
occupied 
by blood vessels 
within the deep 
retinal capillary 
plexus, 
assessed using 
images 
obtained 
by 
OCTA. 
Independent 
Quantitative 
Continued 
Percentage 
(%) 
OCT - A 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 

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FAZ 
Foveal 
Avascular 
Zone 
(mm2) 
Central area of 
the fovea where 
there 
are 
no 
capillaries and is 
free 
of 
blood 
vessels 
Independent 
Quantitative 
Continued 
Mm 2 
OCT - A 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Retinal thickness 
maps: 
central 
zone 
(1 
mm), 
middle zone (3 
mm) and external 
zone (6 mm). 
Measurement of 
retinal thickness 
in 
different 
macular areas. 
Independent 
Quantitative 
Continued 
Micrometers 
(µm). 
OCT - A 
Visit 1. 
Pre-surgical 
Visit 3. Day 
30. 
Visit 4. Day 
90. 
Intraoperative 
complications 
Intraoperative 
complications 
are adverse or 
unexpected 
events 
that 
occur during the 
surgical 
procedure 
and 
may affect the 
patient's 
outcome. 
Independent 
Qualitative 
Nominal 
Absent: 0 
Present: 1 
Standardize
d registration 
Surgery. Day 
3. 
Severity 
of 
intraoperative 
complications 
Severity 
of 
transoperative 
complications 
are adverse or 
unexpected 
events 
that 
occur during the 
surgical 
procedure 
and 
that may affect 
the 
patient's 
outcome. 
Independent 
Qualitative 
Ordinal 
Light: 0 
Moderate: 1 
Severe: 2 
Standardize
d registration 
Surgery. Day 
3. 

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Postoperative 
complications 
Postoperative 
complications 
are 
adverse 
events, 
expected 
or 
unexpected, 
that occur after 
surgery 
and 
affect 
the 
patient's 
recovery. 
Independent 
Qualitative 
Nominal 
  
Absent: 0 
Present: 1 
Standardize
d registration 
Visit 2. 
Visit 3. 
 
Severity 
of 
postoperative 
complications 
Severity 
of 
postoperative 
complications 
are 
adverse 
events, 
expected 
or 
unexpected, 
that occur after 
surgery 
and 
affect 
the 
patient's 
recovery. 
Independent 
Qualitative 
Ordinal 
  
Light: 0 
Moderate: 1 
Severe: 2 
Standardize
d registration 
Visit 2. Day 4. 
Visit 3. Day 
30. 
  
4.6.     SAMPLE SIZE 
a)  Outcome variable: Corrected Visual Acuity measured in ETDRS letters 
- Sampling method: Non-probability by Convenience 
- Power analysis: Variability of corrected visual acuity measured in letters 
on the ETDRS scale 
• Expected variability (𝛿 ): Based on previous studies, we estimate 
the variability of 15 letters. [20, 21, 22, 23] 
• Minimal clinically relevant difference ( 
): The protocol will 
consider a change of 10 ETDRS letters as clinically significant. 
• Significance level ( ⲁ ): 0.05 
• Statistical power (1- β ): 0.8 (80%) 
 
𝑛= #𝑍! + 𝑍"&
# 𝑋 2(𝜎)#
∆#
 
Where: 
 
•  n = Sample size per group 

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• 
= 1.96 ( ⲁ of 0.05) 
 
•  
= 0.20 (with a power of 80%) 
 
• 
= 15 Letters 
 
•  
= Minimal clinically significant difference 10 letters 
 
𝑛=
(1.96 + 0.84)! 𝑋 2(15)!
10!
 
 
𝑛= 3528
100 = 35.28 
 
 
At least 36 patients are needed to ensure that the study has sufficient statistical 
power to detect a 10-letter ETDRS improvement with 95% confidence. 
  
4.7.     DESCRIPTION OF MAIN MANEUVERS 
The following surgical procedure will be performed: PHACO + IOL + 
PPV + ERM peeling + Controlled macular detachment 
4.8.     METHOD 
- 
Patient recruitment: Patients who attend the APEC retinal 
consultation and are assessed by the ophthalmologist in charge as 
candidates will be channeled towards the protocol. 
- 
Once the patient has been evaluated and all inclusion criteria have 
been met, the protocol will be discussed with the patient, the 
procedure will be explained, doubts will be resolved, and possible 
complications will be highlighted. 
- 
The patient is willing to participate in the protocol and must sign an 
informed consent form. 
- 
First Assessment: Visual acuity will be measured with and without 
lenses. The presence or absence of visual phenomena such as 
metamorphopsia will be assessed using the Amsler grid and M-
Charts. Ophthalmological characteristics of the anterior and 
posterior segments will be reviewed under dilation. Intraocular 
pressure will be measured with a digital tonometer (ICare). Finally, 
OCT and OCT-A studies will be recorded and recorded. 

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- 
On the day of the surgical procedure, the procedure will be 
performed at APEC facilities under regional anesthesia and 
conscious sedation. During the surgery, all transoperative details, 
including any complications, will be thoroughly documented and 
reported. This information will be recorded in both the patient's 
medical history and personal file in the protocol. Audiovisual 
material of the procedures will also be collected and stored. 
- 
Second assessment: You will be scheduled for immediate post-
surgical control (within 24 hours) to rule out the presence of 
complications, measurement of visual acuity, and intraocular 
pressure with a digital tonometer (ICare). 
- 
Third assessment: A second post-surgical check-up (30 days) will 
be scheduled at the retinal service outpatient clinic at APEC to rule 
out any complications. The same variables assessed in the first 
assessment will be re-evaluated: visual acuity will be measured 
with and without lenses. The presence or absence of visual 
phenomena such as metamorphopsia will be assessed using the 
Amsler grid and M-Charts. Ophthalmological characteristics of the 
anterior and posterior segments will be reviewed under dilation. 
Intraocular pressure will be measured with a digital tonometer 
(ICare). Finally, OCT and OCT-A studies will be taken and 
recorded. 
- 
Fourth assessment: A third post-surgical check-up will be 
scheduled (three months after surgery) at the outpatient clinic of the 
retina service at APEC to rule out complications. The same 
variables taken in the first assessment will be assessed: visual 
acuity with and without lenses. The presence or absence of visual 
phenomena such as metamorphopsias will be evaluated using the 
Amsler grid and M-Charts. Ophthalmological characteristics of the 
anterior and posterior segments under dilation will be reviewed. 
Intraocular pressure will be measured with a digital tonometer 
(ICare). Finally, OCT and OCT-A studies will be taken and 
recorded. 
- 
At this fourth assessment, the protocol-based follow-up will be 
concluded, and the results found specifically for each patient will be 
explained. Follow-up will then continue with the APEC Retina 
Service. 
  
4.9.     DATA COLLECTION AND ANALYSIS 

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Data collection will be done digitally using previously established collection 
sheets. 
The database will be built in Excel 
Data analysis will be done using the Excel system. 
4.10.  STANDARDIZED METHODS 
- 
Visual Acuity Testing: Distance visual acuity with and without 
correction will be recorded using the ETDRS chart at a distance of 20 
feet. The number of letters read correctly will be recorded. Personnel 
trained with this scale will be required. 
- 
Presence of Metamorphopsia: The presence of metamorphopsia 
will be recorded using the Amsler Grid at a distance of 30 - 40 cm and 
M-Charts with vertical and horizontal metamorphopsia scores. 
- 
OCT acquisition: An OCT scan of the macular area will be 
acquired using the Heidelberg HRA + OCT Spectralis equipment. 
Spec - CAM - 15095 - S3610. Software Version: 7.0.6.0. Retina 
Service. Module 12. Scans: 
- 
Horizontal and vertical Line Scan 30 or ART 100 frames 1536 A – 
Scans 
- 
Dense 49 slices 120 µm 20 o x 20 o 24 A - Scans ART 34 frames 
o Central macular thickness (µm). 
o Thickness of the inner nuclear layer (µm). 
o Presence of ellipsoid zone disruption 
- 
OCT-A taking: OCT-A of the macular area will be taken with the Zeiss 
Angio equipment Plex Elite. Model 9000. Series PE9000-0182.  
o Vascular density RV in superficial and deep plexus (%) 
o FAZ Foveal Avascular Zone (mm2) 
o Retinal thickness maps: central zone (1 mm), middle zone (3 
mm) and external zone (6 mm). 
- 
Standardized surgical technique of PHACO + IOL + PPV + ERM 
peeling + Controlled macular detachment 
* Asepsis and antisepsis (Povidone-iodine 5%) 
* Three 25G sclerotomies: Superonasal, superotemporal and 
inferotemporal 
* Assisted cataract extraction with phacoemulsification and IOL 
placement. 
* Central and peripheral posterior vitrectomy, posterior hyaloid 
detachment assisted with Triamcinolone. 

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* Brilliant blue injection for staining of the internal limiting membrane. 
* MER peeling with limiting membrane forceps. 
* Liquid-air exchange 
- 
Controlled macular detachment 
* After MER peeling, using a Katalyst Sub-retinal cannula 41-gauge 
tip, balanced salt solution (BSS) is administered into the subretinal 
space. 
  
4.11.  ANALYSIS PLAN 
Descriptive Analysis: Means, standard deviations, medians, and 95% 
confidence intervals (CI) will be calculated for the number of ETDRS letters 
before and after surgery in both groups. 
Normality Test: Shapiro-Wilk or Kolmogorov-Smirnov will be used to evaluate 
whether the variable “ETDRS letters earned” follows a normal distribution. 
Repeated measures analysis: The evolution of visual acuity over time will be 
assessed by: 
- 
Repeated measures ANOVA (if data are normal). 
- 
Friedman test (if the data are not normal). 
Bonferroni correction: to avoid type I errors  
Significance Criterion 
- 
A p-value < 0.05 will be considered statistically significant to reject the null 
hypothesis. 
- 
95% confidence intervals (95% CI) will be reported for the difference in 
ETDRS letters between both techniques. 
 
5.  ORGANIZATION 
5.1.     Resources 
5.1.1.   Human resources 
-    Principal Investigator: Dr. Raúl Vélez Montoya 
-    Co-Investigators: 
Dr. Karla Paola García 
Dr. Oriana Gómez Erazo 
Dr. Gisele Vigueras 
5.1.2.   Material resources 
5.2.     Hospital resources 
- 
Optical Coherence Tomography (*3) for each patient 
- 
Optical coherence tomography angiography (OCT-A) (*3) for 
each patient 
- 
Retina Ratings (*4) for each patient 
- 
Refraction Appointment (*4) for each patient 

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
- 
PHACO + IOL + PPV + ERM peeling + Controlled macular 
detachment 
 
5.3.     Financing 
 
Clave
Nombre del servicio
Precio Proyectos 
APEC 2025
Estudios a realizarse
Total
Tomografía de Coherencia óptica: Heilderber HRA + OCT Spectralis. Spec - CAM 
- 15095 - S3610. Software Version: 7.0.6.0. Servicio de Retina. Módulo 12
108
Angiotomografía óptica coherente. ( Lista ApecOCT- adulto)  equipo Zeiss Angio 
Plex Elite. Modelo 9000. Serie PE9000-0182. Servicio de Retina. Módulo 12
108
Valoraciones por Retina 
144
Cita de Refracción 
144
FACO + LIO + VIT
36
Equipo de extracción de Silicón
36
Azul brilante
36
Pinza de pelamiento de Membrana Limitante 
36
Canula Katalyst Sub-retinal 41 gauge tip
36
Total financiado por el APEC:
$0,00
Fecha de inicio del protocolo:
3/02/25
Fecha estimada de término del protocolo:
23/02/26
AUTORIZACIÓN
Dra.Valeria Sánchez Huerta
Directora General
Dra. Matilde Ruíz Cuz
Jefa de Investigación
Elaboró: 
Dra. Karla Paola García. Pre Becaria de Retina
Dra. Oriana Gómez Erazo. Pre Becaria de Retina
Dra. Gisele Vigueras. Pasante del Servicio Social. 
Fecha de realización: 
4/03/25
APEC-INV-PR-01-FO-01
1 de 1                
Rev. 0
                       
Asociación Para Evitar La Ceguera en México I.A.P
Hospital Luis Sánchez Bulnes
Departamento de Investigación
Presupuesto Protocolo: “Resultados funcionales postquirúrgicos en pacientes con membrana epirretiniana sometidos a despegamiento macular controlado.”                                      Número de 
Aprobación: EN PROCESO DE APROBACIÓN DE COMITÉS APEC
Departamento: RETINA   IP: Dr. Raúl Vélez Montoya            N° PACIENTES: 36
C.P. Jorge Aparicio Rojas
Director de Administración y Finanzas
C.P. Mónica Monsalvo Cisneros
Gerente de Contabilidad

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
5.4.     Schedule of Activities for the complete protocol 
 
CALENDAR DATE 
ACTIVITY 
DESCRIPTION OF ACTIVITIES 
TIME IN 
WEEKS 
03 – 
02 / 
2025 
03 – 
03 / 
2025 
01 – 
04 / 
2025 
15 – 
09 / 
2025 
20 – 
10 / 
2025 
03 – 
11 / 
2025 
17 – 
11 / 
2025 
01 – 
12 / 
2025 
29 – 
12 / 
2025 
26 – 
01 / 
2026 
February 
23, 2026 
PRESENTATION OF 
PROTOCOL PROPOSAL 
Drafting of Protocol Proposal and Presentation to Service 
Management 
4 weeks 
X 
 
 
 
 
 
 
 
 
 
 
PRESENTATION 
BEFORE THE ETHICS 
COMMITTEE 
Submission to the APEC Ethics Committee for approval 
4 weeks 
 
X 
 
 
 
 
 
 
 
 
 
PATIENT 
RECRUITMENT AND 
DATA RECORDING 
Total duration of recruitment of all patients 
24 weeks 
 
 
X 
 
 
 
 
 
 
 
 
A.  Presentation of 
protocol to the 
Retina service 
Presentation of the protocol to the Retina service for proper 
referral 
  
 
 
 
 
 
 
 
 
 
 
 
B.  Patient filter 
according to 
inclusion and 
exclusion criteria 
It is assessed whether the participant meets inclusion criteria. 
  
 
 
 
 
 
 
 
 
 
 
 
C.  Visit 0. Day 1. 
Patient filter according to 
inclusion and exclusion 
criteria 
The participant is assessed to determine whether they meet the 
inclusion criteria. Once the assessment has been completed, 
the protocol will be discussed with the patient, the procedure will 
be explained, questions will be answered, and potential 
complications will be highlighted. At the end of the consultation, 
the corresponding informed consent forms will be signed. 
  
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
D.  Visit 1. Day 2. 
 
Visual acuity will be measured in ETDRS letters. The presence 
or absence of metamorphopsia will also be assessed using the 
Amsler grid , M-Charts, and intraocular pressure measurement 
with a digital tonometer (ICare). 
Finally, the previously established macular tomographic 
characteristics will be recorded. 
  
 
 
 
 
 
 
 
 
 
 
 
E.  Surgical 
Intervention. Day 3 
On the day of the surgical procedure, both the intraoperative 
findings and any complications will be detailed. This information 
will be recorded in both the patient's medical history and 
personal file in the protocol. 
  
 
 
 
 
 
 
 
 
 
 
 
F.  
Visit 2. Day 4. 
You will be scheduled for immediate post-surgical control (24 
hours POP) to evaluate possible complications, take visual 
acuity and IOP. 
  
 
 
 
 
 
 
 
 
 
 
 
G.  Visit 3. Day 30. 
A second postoperative follow-up (30 days POP) will be 
scheduled to assess for possible complications, measure visual 
acuity, IOP, evaluate metamorphopsias, and perform OCT and 
OCT-A follow-up. The same variables as those taken in the first 
assessment will be evaluated. 
  
 
 
 
 
 
 
 
 
 
 
 
G.  Visit 4. Day 90. 
A second postoperative follow-up (3 months POP) will be 
scheduled to assess for possible complications, measure visual 
acuity, IOP, evaluate metamorphopsia, and perform OCT and 
OCT-A follow-up. The same variables as those recorded in the 
initial assessment will be evaluated. 
End of monitoring by the protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
DATABASE 
PREPARATION 
The database will be developed with the help of the Excel 
program, including sociodemographic variables, covariates and 
outcome variables using the necessary coding for subsequent 
analysis. 
4 weeks 
 
 
 
X 
 
 
 
 
 
 
 
DATABASE 
DEPURIFICATION 
The variables will be checked to ensure they are correctly filled 
out and any missing data will be corrected. 
2 weeks 
 
 
 
 
X 
 
 
 
 
 
 

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
DESCRIPTIVE 
ANALYSIS OF THE 
DATA 
The descriptive analysis of the variables will be prepared using 
the Excel and Stats system. 
2 weeks 
 
 
 
 
 
X 
 
 
 
 
 
MULTIVARIATE DATA 
ANALYSIS 
The bivariate and multivariate analysis of the variables will be 
carried out using the Excel and Stats system. 
2 weeks 
 
 
 
 
 
 
X 
 
 
 
 
PREPARATION OF THE 
FINAL REPORT OF THE 
PROTOCOL 
Writing the final report 
4 weeks 
 
 
 
 
 
 
 
X 
 
 
 
PRESENTATION OF 
THE FINAL REPORT OF 
THE PROTOCOL 
Presentation of the final report to the Service Management 
1 week 
 
 
 
 
 
 
 
 
X 
 
 
WRITING A SCIENTIFIC 
ARTICLE 
Writing the scientific article 
4 weeks 
 
 
 
 
 
 
 
 
 
X 
 
SCIENTIFIC 
DISSEMINATION 
Submission of an article to a scientific journal 
1 week 
 
 
 
 
 
 
 
 
 
 
X 
  
  
TOTAL 
WEEKS: 
50 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
 
5.5.     Schedule of Activities for Recruitment and Follow-up of 
Participants 
  
 
  
 
 
 
 
 
 

PROTOCOL ID: DMER - 025 
Version: 07 Date: May 20, 2025 
ANNEX I: Informed Consent Form 
  
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