Outcomes of Macular Hole Surgery With Inverted Flap With no Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres

NCT07787390 | Active Not Recruiting

• 1 other identifier: LahoreGeneralH19
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Hole

Keywords

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

Outcome Measures

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.

  3 months after surgery.

Study Arms (2)

Face-Down Posturing Group

EXPERIMENTAL

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

No Face-Down Posturing Group

ACTIVE COMPARATOR

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

Face-Down Postoperative Positioning BEHAVIORAL

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

Face-Down Posturing Group

No Face-Down Postoperative Positioning BEHAVIORAL

Patients were managed without postoperative face-down posturing.

No Face-Down Posturing Group

Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade PROCEDURE

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

Face-Down Posturing Group; No Face-Down Posturing Group

Eligibility Criteria

• Age: 52 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Ahmad Fauzan

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

PA (1)