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Active, not recruitingNCT07787390Updated Sep 10, 2026

Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres

An interventional study of Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade and Face-Down Postoperative Positioning in Macular Hole, sponsored by Lahore General Hospital. Active, not recruiting at 1 site in Pakistan. Open to participants aged 52 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Lahore General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2026, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
52 Years to 84 Years
Sex
All
01

Study summary

This study evaluated the outcomes of surgery for large full-thickness macular holes measuring more than 400 micrometres using the inverted internal limiting membrane flap technique with sulphur hexafluoride (SF6) gas tamponade. The study was conducted at the Department of Ophthalmology, Lahore General Hospital, Lahore. A total of 52 male and female patients aged 52-84 years with full-thickness macular holes were included.

All patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue. Patients were divided into two groups according to postoperative positioning. One group performed postoperative face-down posturing, whereas the other group did not perform face-down posturing. The study examined whether successful closure of large macular holes could be achieved without postoperative face-down positioning after surgery with SF6 gas tamponade.

Patients were followed on postoperative days 1, 7, 30, and 90. The main outcome was anatomical closure of the macular hole, which was assessed using optical coherence tomography (OCT). Successful treatment was defined as complete anatomical closure of the macular hole. The outcomes of patients who performed face-down posturing were compared with those who did not perform postoperative posturing to determine whether face-down positioning was necessary following surgery for macular holes larger than 400 micrometres.

02

Conditions studied

  • Macular Hole

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Keywords

  • Macular Hole
  • Full-Thickness Macular Hole
  • Large Macular Hole
  • Pars Plana Vitrectomy
  • Internal Limiting Membrane
03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's enrollment of 52 is close to the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Lahore General Hospital is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
52 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gender: male and female
  • All patient having age between 52-84 years
  • All the patients with full thickness macular hole
  • All the patients with written

Exclusion criteria

Exclusion Criteria:

  • Patients with high myopia.
  • Patient having age related macular degenerations (AMD).
  • Patient having any chorioretinal disease or Diabetic retinopathy.
  • Secondary MH causes

    • Trauma.
    • Uveitis.
    • Cystic macular edema.
    • Age-related macular degeneration
    • Glaucoma or ocular hypertension
    • corneal opacity
  • Patient with history of previously intraocular or vitrectomy surgery other than uncomplicated cataract surgery.
  • Patient with history of previous laser photocoagulation.
  • Presence of traction on the macula (OCT).
  • Patient with significant media opacity preventing retinal view or poor image quality.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Face-Down Posturing Group

    Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. After surgery, patients performed postoperative face-down posturing.

    Procedure: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade · Behavioral: Face-Down Postoperative Positioning

  • Active comparator
    No Face-Down Posturing Group

    Patients underwent the same 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade. Patients did not perform postoperative face-down posturing.

    Procedure: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade · Behavioral: No Face-Down Postoperative Positioning

Interventions

  • ProcedureMacular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade

    Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery with SF6 gas tamponade.

  • BehavioralFace-Down Postoperative Positioning

    Patients performed face-down posturing after surgery according to the postoperative instructions.

  • BehavioralNo Face-Down Postoperative Positioning

    Patients were managed without postoperative face-down posturing.

06

What researchers measure

Primary outcomes

  1. Anatomical Closure of the Macular Hole on OCT

    Proportion of participants with complete anatomical closure of the macular hole on optical coherence tomography.

    Time frame: 3 months after surgery.

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07787390
Lead sponsor
Lahore General Hospital
Responsible party
Muhammad Irfan Jamil (Principal Investigator, Lahore General Hospital) — Principal investigator
First posted
Aug 26, 2026
Start date
May 1, 2026
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Sep 10, 2026

Study contacts

Ahmad Fauzan
principal investigator · Lahore General Hospital, Lahore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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