Postoperative Same Day Closure of Giant Macular Hole With Silicone Oil

NCT06915948 | Completed

• 2 other identifiers: 202103.U1111-1312-4425
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Holes; Vitrectomy

Keywords

Macular Hole; Giant Large Macular Hole; Silicone Oil; SD-OCT

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Percentage of eyes with Anatomical Closure of Macular hole

  2 weeks post surgery , 1 month Post Silicone oil removal

• Role of Hole Forming Factor (HFF) in predicting Hole Closure

  at day 1, 2 weeks post surgery

• Role of Diameter Hole Index (DHI) in predicting Hole Closure

  at day 1, 2 weeks post surgery

• Mean Diameter Hole Index

  2 weeks post surgery

• Mean Hole Forming Factor

  2 weeks post surgery

Interventions

Macular Hole Surgery PROCEDURE

Pars Plana Vitrectomy with ILM peeling with silicone oil tamponade

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahalia Foundation Eye Hospital: lead

Study Sites (1)

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Rajkumar Maheshwari, MS

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• Amrutha S, DNB

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• Saurav Mahajan, MS

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• Sajeev C Jacob, MS

  Ahalia Foundation Eye Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor Adjunct

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: April 8, 2025
• Study Start: May 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)