Retinal Displacement After Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment
Conditions: Retinal Detachment, Metamorphopsia, Aniseikonia
Sponsor: Unity Health Toronto

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
STUDY PROTOCOL (Version 1, 1/17/2018)  
Title: Retinal displacement after scleral buckling (SB) versus scleral buckle 
combined with vitrectomy (PPV+SB) for the management of primary retinal 
detachment: ALIGN SB vs. PPV-SB. An extension of the study of “Retinal 
displacement after pneumatic retinopexy (PnR) versus vitrectomy (PPV) for the 
management of primary retinal detachment (ALIGN) NCT04089033.” 
Principal Investigators:  
Dr. Rajeev Muni  
Dr. Carolina Francisconi 
Co-investigators:  
Dr. Alan Berger  
Dr. Filiberto Altomare  
Dr. David Wong  
Dr. Louis Giavedoni 
Dr. David Chow 
Dr. Edwin Ryan 
Dr. Shaina Rubino 
Dr. Aditya Bansal 
Study coordinator:  
 
 
Setting:  
 
I. Background  
Retinal detachment  
Rhegmatogenous retinal detachment (RRD) is an acute, sight threatening condition, 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
with an incidence of approximately 10 per 100,000 people.1 During normal ageing, the 
transparent vitreous gel (see figure 1:A), which fills the eye, liquefies and shrinks, and 
eventually detaches in 80% of the eyes. When detachment of the gel occurs, a tear in 
the retina may form (see figure 1:B). Liquified gel may now enter under the retina via the 
retinal tear (see figure 1:C), resulting in detachment of the retina (see figure 1:D). Once 
retinal detachment occurs, sight loss usually develops within several hours to days.  
Figure 1: Retinal detachment  
 
Factors that predispose an individual to developing retinal detachment are myopia (near 
sightedness), advancing age, trauma, and certain hereditary conditions.2 Without any 
surgical intervention by a vitreoretinal surgeon, retinal detachment almost invariably 
results in permanent sight loss in the affected eye. There is an increased risk of delayed 
visual rehabilitation the longer the wait for surgery is.3 Interventions for rhegmatogenous 
retinal detachment may include Scleral Buckling (SB), Pneumatic retinopexy (PnR), 
Pars Plana Vitrectomy (PPV), and PPV+SB in which the primary objectives are to close 
and seal the retinal break and reattach the neurosensory retina to the RPE.4-10 The 
choice of which procedure to perform depends on the clinical examination and the 
surgeon’s discretion as to which will be best for the patient in that specific scenario.  
Interventions for retinal detachment Pneumatic retinopexy (PnR) has been employed 
to repair retinal detachments since the late 1980s and is a minor surgical intervention, 
carried out in a treatment room. The initial success rate (i.e. the proportion of patients in 
whom the retina becomes attached after one treatment) is quoted as approximately 
70%.5-7 PnR is carried out under topical or local anaesthetic (a freezing injection under 
the conjunctiva, the superficial skin on the eye). The procedure involves injection of a 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
small gas bubble into the eyeball via a fine needle. This step takes a maximum of 15 
minutes. Two gases can be injected into the eye: perfluoropropane (C3F8), which lasts 
6 weeks, and sulfahexafluoride (SF6), which lasts about 2 weeks. Both are non-toxic, 
equally effective, have been validated for this use, and are widely used amongst retina 
surgeons in the world. After injection of the gas bubble, the patient is required to 
maintain a strict ‘head posture’ (for example, head tilt to left) for up to 10 days. The 
purpose of this ‘head posture’ is to align the gas bubble (which floats within the eye) to 
the retinal tear. The buoyant force of the gas bubble, as well as its surface tension, act 
to reattach the detached retina over several days. The gas bubble spontaneously 
dissipates after 2-6 weeks, depending on the gas selected. Additionally, laser treatment 
or cryotherapy is carried out either before or 1-2 days after injection of the gas bubble, 
to secure the retinal tear. Without this second step, the retina would re-detach once the 
gas bubble dissipates. Both laser and cryotherapy are widely accepted methods of 
securing the tears in the retina and both are considered equally safe and effective. In 
patients where the retina does not reattach with PnR alone, vitrectomy surgery (PPV) or 
repeat PnR is needed (see below).8 However, the minority of patients who go on to 
need repeat treatment encounter similar final anatomical success rates and will 
experience the same gain in vision as those patients who underwent PPV in the first 
place.9,11  
Vitrectomy surgery (PPV) involves ‘keyhole’ surgery to the eyeball, via three tiny (23/25 
gauge) incisions to the sclera. This procedure is carried out in the operating room, 
under regional anaesthetic (a freezing injection to the retro-bulbar space, the space 
behind the eyeball, where nerves which sense pain and control eye movement are 
situated) plus sedation (medication to reduce patient anxiety). During PPV, the vitreous 
gel is removed from the eye using a fine metal instrument called a ‘vitrector’. The 
vitreous gel is removed to allow space for a larger gas bubble than is possible in PnR, 
and also to relieve any vitreous traction which may otherwise impair reattachment of the 
retina. A large gas bubble (same gases as mentioned for PnR) is injected (to reattach 
the retina, as in PnR), and laser or cryotherapy is applied around the retinal tear to 
secure it (as in PnR). After treatment, a patient may be required to maintain a ‘head 
posture’ (for example, head tilt to left) for up to one week. The purpose of this ‘head 
posture’ is to support the area of the retinal tear optimally, by ‘floating’ the gas bubble 
up against it. As the gas bubble is larger in PPV, the head posturing requirements are 
less strict. The gas bubble reabsorbs after 2-6 weeks, depending on the gas selected. 
The surgery takes 1-1.5 hours. The success rate (i.e. the proportion of patients in whom 
the retina becomes attached after one treatment) is reported as being as high as 90% in 
the scientific literature.7,12,13  
Scleral buckling (SB) is another method used for repair of RD that involves encircling 
the eye with a silicone band, and may or may not involve the use of a gas bubble. This 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
has been reported to have better visual results than PPV in phakic patients.15  
Another surgical technique for repair of RD is PPV combined with SB (PPV/SB), and 
this is used commonly in treatment of larger or more complex detachments.  The 
surgery combines the two techniques, and involves the use of a large and often long-
acting gas bubble similar to what is done in PPV surgeries. 
All the treatment options may be associated with complications such as bleeding, 
infection, increased intraocular pressure or cataract. The risk of a sight threatening 
complication such as a severe intraocular infection or hemorrhage is less than 1:1000. 
The risk of cataract development (clouding of the lens, requiring cataract extraction 
surgery) is less in PnR11,14 and SB compared to PPV.15  
 
 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
Distortion and retinal displacement after retinal detachment repair  
Image distortions such as metamorphopsia and micropsia are common complaints after 
surgery for retinal detachment. In 2010 Shiragami et al were the first to demonstrate 
hyper-fluorescent lines, adjacent to the retinal blood vessels in Fundus auto-
fluorescence imaging (FAF) of the retina after retinal detachment (RD) repair surgery.26 
They proposed a theory in which these lines which are called also Retinal Vessel 
Printing (RVP) correspond to the area where the retinal blood vessels were located 
before the retinal detachment. According to this theory the RVP in FAF imaging is due 
to increased metabolic activity of RPE cells. Prior to surgery these RPE cells were 
obscured to light rays by retinal blood vessels while after surgery, due to displacement 
of the retina, these RPE cells became exposed to the light which leads to increase in 
the cells metabolic activity. This increase in metabolism is thought to be the cause for 
the hyper fluorescence seen in FAF imaging. Displacement of the retina after RD repair 
surgery can serve as anatomy basis of vision distortion. Moreover, these reference lines 
allow us to quantify the displacement of the retina after retinal detachment surgeries. By 
doing this, we can compare retinal displacement of different retinal detachment repair 
surgeries and may reduce post operation visual distortion.     
Since Shiragami’s first report, several other studies looked into retinal displacement 
after RD repair26-32, epiretinal membrane33 and macular hole34. Codenotti et al have 
shown that retinal displacement ratio is higher in patients with intravitreal gas compare 
to patients with silicon oil (71.4% vs. 22.2%).27 Lee et al proposed a way of quantifying 
the rotational displacement of the retina.28 They showed that there is more than a 
simple rotation and probably also a temporal stretch of the retina. Recently Dell’omo 
published the biggest study so far of 125 patients after pars plana vitrectomy (PPV) with 
35.2% of patient showed signs of retinal displacement.30 
Recently we showed in PIVOT trial that patients after pneumatic retinopexy has less 
vertical distortion than patients after PPV. To the best of our knowledge, no study so far 
looked into retinal displacement after Pneumatic Retinopexy. Moreover, wide field FAF 
was not used in previous studies. We think there is a reason to believe that Pneumatic 
Retinopexy will cause less retinal displacement than PPV. Thus, we propose a 
prospective cohort study which will compare retinal displacement of patients after RD 
repair by PPV versus Pneumatic Retinopexy. 
In addition, we wish to include VitreoRetinal Surgery, PA in Minnesota and Bhagwan 
Mahavir VitreoRetinal Services, Sankara Nethralaya in India as the site to study retinal 
displacement following RD repair using either SB or PPV with SB, since this practice 
has a much higher volume of those surgical methods. 
 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
II. Aim (SB and PPV+SB arm) 
To compare retinal displacement and visual distortion of primary retinal detachment 
repair following scleral buckling (SB) versus scleral buckle combined with pars plana 
vitrectomy (PPV+SB).  
III. Study design  
(i) Hypothesis The primary study hypothesis is that scleral buckling alone may cause 
less retinal displacement and less visual distortion at the first 12 months for patients 
with primary retinal detachment than other methods.  
(ii) Experimental design A prospective, cohort trial, evaluating scleral buckling alone 
and scleral buckling combined with vitrectomy outcomes for patients with primary retinal 
detachment.  
(iii) Participants Patients presenting to vitreo-retinal service with rhegmatogenous 
retinal detachment. Eligibility for study participation will be ascertained by the examining 
physician at the time of presentation:  
 Inclusion criteria:   
• Age ≥ 18 
• Diagnosis of macula off primary rhegmatogenous retinal detachment 
 
Exclusion criteria:  
• Previous retinal detachment and/or retinal detachment repair surgery in the study 
eye 
• Retinal detachment with macula on. 
• Patients with other retinal pathologies causing structural changes to the retina in 
the study eye, such as diabetic retinopathy, previous vascular occlusion (artery 
or vein occlusion), macular dystrophy, among others. 
• Previous vitreoretinal surgery in the study eye 
• Inability to come for follow ups up to 12 months. 
• Inability to take FAF imaging due to neck stiffness or other medical issue. 
• Inability to maintain post operation head positioning 
• Mental incapacity 
• Inability to sign on informed consent. 
• Patient is unwilling or unable to follow or comply with all study related procedures 
or to sign informed consent form 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
 
Criteria for participant withdrawal from study: - Patient withdraws consent  
(v) Interventions  
The only interventions in the study are performed at the 3 and 12 month postoperative 
visit, and include fundus imaging (FAF and OCT), and sensory testing with the M chart 
and the Aniseikonia test, as detailed below. 
Participants will be chosen from those undergoing either scleral buckling alone or 
scleral buckling combined with vitrectomy for repair of a macula-off retinal detachment.  
Patients are not randomized to the procedure, rather the procedure is chosen by the 
surgeon in the best interests of the patient. 
In the event of primary intervention failure (i.e. failure of retinal re-attachment following 
primary intervention), the decision to proceed with secondary intervention, and the 
nature of such intervention, will rest with the treating physician in conjunction with the 
patient. Secondary intervention may involve any surgical procedure, as deemed 
clinically appropriate.  
Note: Additional laser retinopexy, cryotherapy, gas injection or head positioning are not 
considered a failure.  
 (vi) Timing of observations See flow diagram (Appendix 1)  
Imaging 
Fundus AutoFluorescence (FAF) 
Fundus autofluorescence (FAF) imaging is a noninvasive imaging method and requires 
relatively little time. It highlights the fluorophores accumulating in lipofuscin (LF) within 
retinal pigment epithelium cells (RPE). No radiation is involved therefore this imaging 
method is safe without any clear contraindications. 
M Chart 
Recently, several tools have been developed for quantification of metamorphopsia 
severity including M-CHARTS (Inami Co., Tokyo, Japan). In the patients with 
metamorphopsia, a straight line appeared curved or irregular. On M-CHARTS, straight 
lines are replaced with dotted lines, and the dot intervals (range: 0.2° - 2.0°) are 
changed from fine to coarse. With increasing dot interval, the line distortion decreases 
until the dotted line becomes straight. The visual angle that denoted the dot interval of 
the line seen as straight was considered as the patient’s M-CHARTS score. When a 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
patient was tested with vertical dotted lines, the result was defined as the vertical M-
CHARTS score. After the M-CHARTS were rotated 90°, the horizontal M-CHARTS 
score also was measured according to horizontal dotted lines35. 
Aniseikonia test 
Aniseikonia is a phenomenon in which the size or shape of perceived images differs 
between eyes. The anomaly is reported to be associated with interocular differences in 
refractive error and some retinal diseases. Following successful repair for 
rhegmatogenous retinal detachment, some patients have complained that objects 
appeared distorted in size or shape. The Aniseikonia Test measures the ratio of image 
size difference between the 2 eyes36. 
(vii) Outcome measures  
Primary outcome:  
- retinal displacement by the presence of retinal vessels printing on FAF imaging. 
Secondary outcome: 
- Visual Distortion measured with M chart. 
- Anisokenia testing. 
- Optical Coherence Tomography (OCT) changes. 
- Metamorphopsia according to the patient symptoms.    
- Visual acuity (ETDRS 12 months post intervention) 
- Metamorphopsia questionnaire  
(viii) Recruitment plan   
Recruitment will begin after Research Ethics Board approval has been granted and will 
continue until the required number of patients are enrolled and have completed the 
study.  Patients visiting the retina clinic with primary RRD will be given the option to 
participate if they meet the criteria.  Based on our clinic’s routine volume, we anticipate 
recruiting approximately 4 patients per sub-study per week, with complete recruitment 
over a 12-month period. Each patient will be followed for 12 months.  
  
(ix) Screening Procedures 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
Patients will be screened by the investigators in the same manner as standard 
patients.  The tests to be performed are typically used for diagnosis and follow-up of 
retinal detachment: best-corrected Snellen visual acuity assessment, slit-lamp exam, 
tonometry, fundoscopy, and Optical Coherence Tomography (OCT) at every visit. 
ETDRS visual acuity (ETDRS - ‘Early treatment of Diabetic Retinopathy Study’ – this 
study defined a method of visual acuity assessment that has become the gold standard 
for use in eye research) will be assessed at 12 months after the treatment for RRD. 
Assessment of Clinical Parameters: 
The following clinical data will be obtained from each patient: age, gender, extent of the 
detachment (quadrants), duration of subjective symptoms (days), vitreous status 
(presence/absence of vitreous hemorrhage), macular status (attached/on or 
detached/off), the location of main retinal tears (fundus sketch), refractive power 
(emmetropic, hyperopic, myopic <6 or > 6 diopters, lens status (phakic or 
pseudophakic) and medications in use. 
   
(x) Sample size  
Sample sizes were calculated to appropriately power the study. A total sample size of 
40 subjects with macula-off detachments undergoing scleral buckles will be recruited. A 
second group of 40 subjects with macula-off retinal detachments undergoing combined 
vitrectomy an scleral buckle placement will also be recruited. Anticipating a dropout rate 
of 20%, we calculated a total of 100 patients in the entire study.   
 
 IV. Data management  
Initial data collection (clinical examination findings, visual acuity, and questionnaire 
data) will take place in a paper format. Subsequently, this data will be transferred to a 
digital database (Microsoft Excel). Paper data will be stored in a locked filing cabinet in 
the principal investigator’s office and away from the study data, and will be destroyed 
once digital data entry has taken place. The digital spreadsheet will be held on a 
password protected computer in a locked room, and an encrypted memory stick. At 
recruitment, each patient’s name and date of birth will be obtained to facilitate onward 
administration of follow-up appointments and safety monitoring and stored on a face 
sheet (master linking log). The face sheets will be stored in a locked filing cabinet, away 
from the study data. Each patient will be allocated a unique study identification number, 
which will be used to label all paper and digital data pertaining to that patient. The face 
sheets (master linking log) and all paper/electronic data will be destroyed once 
publication takes place. The de-identified study data will be destroyed five years after 
publication has taken place.  
V. Consent:  

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
Written, informed consent for imaging and sensory testing as part of the study will be 
obtained from each participant. Important: the clinical care of the patient will not be 
affected by the patient’s participation or non-participation in this study of post-surgery 
imaging and sensory testing. Given that 12-month followup can be problematic for 
patients who live a great distance from the study sites, a 20% dropout rate is 
anticipated. There is no charge to the patient for the sensory testing, which is the only 
element that differs from standard care.  
On no occasion should consent be obtained by the treating physician or study 
investigator. During working hours: The study will be introduced to the patient by the 
examining physician. Interested patients are directed to Research Technician who will 
obtain informed consent.  
Late evenings / weekends: Informed consent may instead be obtained by the 
vitreoretinal surgery fellow (assuming that they are not the treating physician and will 
not be involved in the patient’s surgery). The resident/fellow will be familiar with both 
interventions (SB and PPV+SB), the nature of the study and trained to the consent 
discussion and obtaining written informed consent.  As retinal detachments are usually 
unilateral conditions, patients can still read the informed consent. If the patient has any 
bilateral visual impairment, a witness, usually being the accompanying relative of the 
patient or a staff member not involved in the study, will also be present.  
VI. Data Analysis:  
Continuous data: Data will be checked for normality. Normal data will be compared 
using a non-paired t-test. Non-normal data will be compared using non parametric tests. 
Categorical data: Chi squared test. Coefficients with 95% confidence intervals will be 
reported. A p-value of 0.05 will be considered for statistical significance. Data will be 
analyzed using SPSS (SPSS Inc., Chicago, IL). Per protocol analysis will be used.  
VII. Safety Monitoring Plan 
 This study will be conducted in accordance to the Declaration of Helsinki. The local 
principal investigator will meet monthly with study team members to review the progress 
of the study. Furthermore, to ensure that all members are performing their roles in 
accordance with the professional obligations described in this Ethics Application, the 
Principal Investigator will randomly check on the study coordinators and participants. 
Patients will be made fully aware of the risks and benefits of the procedures. Patients 
will be assessed before and after the treatment and will be closely monitored throughout 
the study. Complications will be managed by highly trained hospital staff including 
ophthalmologists, nurses, allied health professionals and technicians as per standard of 
care. 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
VIII. Funding   
All aspects of clinical care, including procedures visits and exams, carried out as part of 
the study represent standard of care. 
  
Support staff: Our research technicians are already salaried employees within the 
department. Part of the existing job description is assisting Fellow’s research, and 
therefore no additional funds will be required. 
Expenses with printing and copying will be absorbed by the principal investigator’s 
(Dr…………..) office. 
 
 
 
 

Retinal Displacement after scleral buckle vs pars plana vitrectomy with scleral buckle for primary 
rhegmatogenous retinal detachment – Protocol # 18-085, version 1, 1/17/2018 
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