Clinical trial NCT06915948: Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil
Official title: Postoperative Anatomical Closure of Idiopathic Chronic Giant Macular Hole on the Same Day Determined by Spectral Domain Optical Coherence Tomography for Macular Hole Surgery With Silicone Oil Tamponade
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Vitrectomy
Keywords: Macular Hole
Giant Large Macular Hole
Silicone Oil
SD-OCT
Lead sponsor: Ahalia Foundation Eye Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Patients (South Indians) who attended Retina OPD in Ahalia Foundation Eye Hospital, Palakkad, Kerala was selected to participate in the study

Brief summary: Patients with stage 3 and 4 macular holes of size \&gt;700 microns who underwent pars plana vitrectomy, Internal limiting Membrane peeling and silicone oil tamponade were followed at day 1 , 2 weeks and 1 month post silicone oil removal and anatomical closure of macular hole assessed at all intervals

Detailed description: Patients who attended Retina OPD in Ahalia Foundation Eye Hospital, Palakkad were selected to participate in the study

Basic demographic profile which includes name, age, gender , address was noted .

Structured questionnaire was used to collect information about the presence of any systemic risk factors like diabetes mellitus, hypertension, any prior retinal surgery and high myopia .

Preoperatively , all subjects will be tested for BCVA , intraocular pressure measurement, slit lamp bio-microscopy of anterior segment and indirect non contact bio-microscopy of the fundus with 20D lens will be documented .

Using spectral domain optical coherence tomography diagnosis of macular hole was confirmed and hole form factor and diameter hole index calculated based on the findings in optical coherence tomography.

Patients with stage 3 and 4 macular holes of size \&gt;700 u who underwent pars plana vitrectomy, ILM peeling and silicone oil tamponade were shortlisted.

Patients follow up was done on day 1, 2 weeks and 1 month post silicone oil removal .

For each follow up , BCVA with silicon oil and intraocular pressure was measured and indirect noncontact bio-microscopy examination of the macula was examined. Assessment of macula was done using OCT on day 1, 2 weeks and 1 month post silicone oil removal .

In all patients the anatomical closure of macular hole was assessed on day 1, 2 weeks and 1 month post silicone oil removal .

Statistical methods

* The information recorded on the data collection forms were uploaded in an excel sheet and data were analyzed using IBM SPSS version 20.
* To obtain the characteristic of categorical variables, frequency and percentage were applied.
* To obtain the characteristic of numerical variables, mean and standard deviation were used.
* Chi square test/ Fisher's exact test was used to find association between HFF, DHI, gender with hole closure type of closure.
* Students t test and Man Whitney U test were performed to compare the average values of numerical parameters such as age, BCVA with hole closure, type of closure, HFF, DHI.
* Paired t test was used to compare the pre-Op and Final BCVA. P-value \&lt;0.05 was consideredto denote statistical significance.
* ANOVA was used wherever we had to compare numerical data/means between 3 groups of type of hole closure- open vs type I vs type II closure.

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic chronic giant macular hole more than 700 micron size confirmed by indirect biomicroscopy and optical coherence tomography.
* Patients who give a valid informed consent
* Patients who underwent surgery

Exclusion Criteria:

* High myopic patients ( \>10 D)
* Patients with history of ocular trauma
* Patients with history of any macular surgery
* Rhegmatogenous retinal detachment associated with macular hole
* Patients having vision loss due to other ocular comorbidities- glaucoma , macular pathology or vitreous hemorrhage.

Primary outcomes:
measure: Percentage of eyes with Immediate Anatomical Closure of Macular hole
timeFrame: Day 1
measure: Percentage of eyes having Type I Closure of Macular hole
timeFrame: Day 1; 2 weeks after surgery ; 1 month post silicone oil removal
measure: Percentage of eyes having Type II Closure of Macular hole
timeFrame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
measure: Percentage of eyes having Open Macular hole
timeFrame: At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
measure: Adverse events
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of eyes with Anatomical Closure of Macular hole
timeFrame: 2 weeks post surgery , 1 month Post Silicone oil removal
measure: Role of Hole Forming Factor (HFF) in predicting Hole Closure
timeFrame: at day 1, 2 weeks post surgery
measure: Role of Diameter Hole Index (DHI) in predicting Hole Closure
timeFrame: at day 1, 2 weeks post surgery
measure: Mean Diameter Hole Index
timeFrame: 2 weeks post surgery
measure: Mean Hole Forming Factor
timeFrame: 2 weeks post surgery
measure: Visual Outcomes
timeFrame: Pre-operative (baseline) and 1 month post Silicone oil removal
measure: Resurgeries
timeFrame: 6 months
measure: Reopened Holes
timeFrame: 6 months
measure: Adverse events
timeFrame: 3 months
measure: Face down positioning
timeFrame: 1 month
Other outcomes:
Locations:
city: Palakkad
country: India
facility: Ahaliafoundation Eye Hospital
state: Kerala
Study officials:
affiliation: Ahalia Foundation Eye Hospital
name: Rajkumar Maheshwari, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahalia Foundation Eye Hospital
name: Amrutha S, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahalia Foundation Eye Hospital
name: Saurav Mahajan, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ahalia Foundation Eye Hospital
name: Sajeev C Jacob, MS
role: STUDY_CHAIR
References: