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NCT Number: NCT07787390

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

52 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent

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.

Treatment and study plan

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 Postoperative Positioning

Behavioral

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

No Face-Down Postoperative Positioning

Behavioral

Patients were managed without postoperative face-down posturing.

Primary outcomes

  1. Anatomical Closure of the Macular Hole on OCT

    Time frame: 3 months after surgery.

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

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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