Macular HoleNCT07787390
Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
A study testing Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Face-Down Postoperative Positioning and No Face-Down Postoperative Positioning in people with Macular Hole, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 52 to 84 years
- Conditions the study is for
- Macular Hole
- What is being tested?
- Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Face-Down Postoperative Positioning and No Face-Down Postoperative Positioning
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with high myopia.
- Patient having age related macular degenerations (AMD).
- Patient having any chorioretinal disease or Diabetic retinopathy.
- Secondary MH causes
- Trauma.
- Uveitis.
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- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
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
- Being tested
- Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Face-Down Postoperative Positioning, No Face-Down Postoperative Positioning
- Keywords
- Macular Hole, Full-Thickness Macular Hole, Large Macular Hole, Pars Plana Vitrectomy, Internal Limiting Membrane
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas TamponadeProcedure or surgery
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery with SF6 gas tamponade.
Face-Down Postoperative PositioningBehavioural
Patients performed face-down posturing after surgery according to the postoperative instructions.
No Face-Down Postoperative PositioningBehavioural
Patients were managed without postoperative face-down posturing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade; Behavioral: No Face-Down Postoperative Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical Closure of the Macular Hole on OCT
Proportion of participants with complete anatomical closure of the macular hole on optical coherence tomography.
Measured: 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Ahmad Fauzan, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787390
- Sponsor's protocol ID
- LahoreGeneralH19
- Status last verified
- Sep 2026
- First submitted
- 22 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
- ClinicalTrials.gov ID
- NCT07787390
- Acronym / sponsor ID
- LahoreGeneralH19
- Conditions
- Macular Hole
- Keywords
- Macular Hole, Full-Thickness Macular Hole, Large Macular Hole, Pars Plana Vitrectomy, Internal Limiting Membrane
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-Down Posturing Group | Experimental | Procedure: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Behavioral: Face-Down Postoperative PositioningPatients 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. |
| No Face-Down Posturing Group | Active comparator | Procedure: Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Behavioral: No Face-Down Postoperative PositioningPatients 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. |
Who may qualify
- Ages
- 52 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Patients with high myopia.
- Patient having age related macular degenerations (AMD).
- Patient having any chorioretinal disease or Diabetic retinopathy.
- Secondary MH causes
- Patient with history of previously intraocular or vitrectomy surgery other than uncomplicated cataract surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas TamponadePatients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery with SF6 gas tamponade. | Procedure or surgery | Face-Down Posturing Group, No Face-Down Posturing Group |
| Face-Down Postoperative PositioningPatients performed face-down posturing after surgery according to the postoperative instructions. | Behavioural | Face-Down Posturing Group |
| No Face-Down Postoperative PositioningPatients were managed without postoperative face-down posturing. | Behavioural | No Face-Down Posturing Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Fauzan principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular Hole Surgery With Inverted Internal Limiting Membrane Flap and SF6 Gas Tamponade, Face-Down Postoperative Positioning and No Face-Down Postoperative Positioning in people with Macular Hole, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical Closure of the Macular Hole on OCT (time frame: 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.