Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil (GiantMH-SO)

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

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

Study Overview

• Status: Completed
• Conditions: Vitrectomy; Macular Holes
• Intervention / Treatment: Procedure: Macular Hole Surgery

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• India
  • Kerala
    • Palakkad, Kerala, India, 678557
      • Ahaliafoundation Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eyes with Immediate Anatomical Closure of Macular hole	Percentage (%) of eyes with Immediate Anatomical Closure of Macular hole on same day	Day 1
Percentage of eyes having Type I Closure of Macular hole	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	Day 1; 2 weeks after surgery ; 1 month post silicone oil removal
Percentage of eyes having Type II Closure of Macular hole	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	At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
Percentage of eyes having Open Macular hole	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	At Day 1, 2 weeks after surgery and 1 month post Silicone oil removal
Adverse events	Any adverse events	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eyes with Anatomical Closure of Macular hole	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	2 weeks post surgery , 1 month Post Silicone oil removal
Role of Hole Forming Factor (HFF) in predicting Hole Closure	Number of eyes with HFF <0.5 achieving hole closure; Number of eyes with HFF >0.5 achieving hole closure	at day 1, 2 weeks post surgery
Role of Diameter Hole Index (DHI) in predicting Hole Closure	Number of eyes with DHI <0.5 achieving hole closure; Number of eyes with DHI >0.5 achieving hole closure	at day 1, 2 weeks post surgery
Mean Diameter Hole Index	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	2 weeks post surgery
Mean Hole Forming Factor	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	2 weeks post surgery
Visual Outcomes	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	Pre-operative (baseline) and 1 month post Silicone oil removal
Resurgeries	No. of eyes that underwent resurgery for open macular hole No. of eyes that underwent resurgery for reason other than open macular hole	6 months
Reopened Holes	Number of hole reopen cases , even under silicone oil	6 months
Adverse events	Any adverse events in 3 months follow up .	3 months
Face down positioning	To find out relevance for maintaining face down positioning	1 month

Collaborators and Investigators

• Sponsor: Ahalia Foundation Eye Hospital
• Investigators: Principal Investigator: Saurav Mahajan, MS, Ahalia Foundation Eye Hospital; Principal Investigator: Rajkumar Maheshwari, MS, Ahalia Foundation Eye Hospital; Principal Investigator: Amrutha S, DNB, Ahalia Foundation Eye Hospital; Study Chair: Sajeev C Jacob, MS, Ahalia Foundation Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: August 24, 2024
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: SD-OCT; Macular Hole; Giant Large Macular Hole; Silicone Oil
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 202103.; U1111-1312-4425 (Other Identifier: WHO UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No