Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

Completed

• Conditions: Macular Holes; Vitrectomy

• Registration Number: NCT06915948
• Lead Sponsor: Ahalia Foundation Eye Hospital

Brief Summary

Patients with stage 3 and 4 macular holes of size \>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 \>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 \<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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-09-30
• Study First Submitted: 2024-08-24
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of eyes with Immediate Anatomical Closure of Macular hole	Day 1	Percentage (%) of eyes with Immediate Anatomical Closure of Macular hole on same day
Percentage of eyes having Open Macular hole	At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal	* Percentage (%) of eyes having Open Macular hole at Day 0; * Percentage (%) of eyes having Open Macular hole at 2 weeks; * Percentage (%) of eyes having Open Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal
Adverse events	Day 1	Any adverse events
Percentage of eyes having Type I Closure of Macular hole	Day 1; 2 weeks after surgery ; 1 month post silicone oil removal	* Percentage (%) of eyes having Type I Closure of Macular hole at Day 0; * Percentage (%) of eyes having Type I Closure of Macular hole at 2 weeks; * Percentage (%) of eyes having Type I Closure of Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal
Percentage of eyes having Type II Closure of Macular hole	At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal	* Percentage (%) of eyes having Type II Closure of Macular hole at Day 0; * Percentage (%) of eyes having Type II Closure of Macular hole at 2 weeks; * Percentage (%) of eyes having Type II Closure of Macular hole 1 month post Silicone oil removal in eyes undergoing Silicone oil removal

Secondary Outcome Measures

Name	Time	Method
Mean Diameter Hole Index	2 weeks post surgery	* Mean Preoperative Diameter Hole Index(DHI) in eyes with Type I closure of macular hole; * Mean Preoperative Diameter Hole Index(DHI) in eyes with Type II closure of macular hole; * Mean Preoperative Diameter Hole Index(DHI) in eyes with Open macular hole
Mean Hole Forming Factor	2 weeks post surgery	* Mean Preoperative Hole Forming Factor(HFF) in eyes with Type I closure of macular hole; * Mean Preoperative Hole Forming Factor(HFF) in eyes with Type II closure of macular hole; * Mean Preoperative Hole Forming Factor(HFF) in eyes with Open macular hole
Visual Outcomes	Pre-operative (baseline) and 1 month post Silicone oil removal	Visual Acuity In LogMAR (logarithm of the Minimum Angle of Resolution) units Pre-operatively (baseline) and after 1 month of silicone oil removal excluding eyes that needed resurgery
Resurgeries	6 months	No. of eyes that underwent resurgery for open macular hole No. of eyes that underwent resurgery for reason other than open macular hole
Reopened Holes	6 months	Number of hole reopen cases , even under silicone oil
Adverse events	3 months	Any adverse events in 3 months follow up .
Percentage of eyes with Anatomical Closure of Macular hole	2 weeks post surgery , 1 month Post Silicone oil removal	* Percentage (%) of eyes with Anatomical Closure of Macular hole at 2 week follow up; * Percentage (%) of eyes with Anatomical Closure of Macular hole at 1 month post silicone oil removal
Role of Hole Forming Factor (HFF) in predicting Hole Closure	at day 1, 2 weeks post surgery	* Number of eyes with HFF \<0.5 achieving hole closure; * Number of eyes with HFF \>0.5 achieving hole closure
Role of Diameter Hole Index (DHI) in predicting Hole Closure	at day 1, 2 weeks post surgery	* Number of eyes with DHI \<0.5 achieving hole closure; * Number of eyes with DHI \>0.5 achieving hole closure
Face down positioning	1 month	To find out relevance for maintaining face down positioning

Trial Locations

Locations (1)

Ahaliafoundation Eye Hospital; 🇮🇳 Palakkad, Kerala, India