Macular hole surgery using internal limiting membrane peeling using a novel technique

Limited versus Conventional Internal limiting membrane peeling in Macular hole surgery â?? Structural and functional outcome comparison

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020381

Enrollment

Registered

2019-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H358- Other specified retinal disorders

Interventions

Intervention1: Pars Plana Vitrectomy with ILM peeling: After detailed consent, three standard pars plana ports will be made with continuous infusion running through the inferotemporal port. Core vitre

the excess dye will be removed after using active suction. An internal limiting membrane will be grasped with Eckardt ILM forceps and will be peeled off depending on the randomisation. 360 degree ILM

the excess dye will be removed after using active suction. An internal limiting membrane

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 50 years of age and of any gender 2. Patients either pseudophakic or phakic having primary idiopathic macular holes stage 3 and stage 4 with healthy optic nerve. 3. Macular hole of size less than 400 microns

Exclusion criteria

Exclusion criteria: 1. Inability to maintain postoperative position 2. Previous ocular surgery 3. Traumatic macular holes 4. No other ocular disease apart from Macular hole such as glaucoma, corneal opacity and significant cataract 5. Media opacity not allowing good quality OCT scans • The patients were explained the study and consent process and the prospective participant were invited to take part in the study.

Design outcomes

Primary

Measure	Time frame
1. To compare structural outcome (Hole Closure) between two groups. 2. To compare functional outcome (Changes in Retinal thickness, RNFL thickness, macular ganglion cell layer thickness and mf ERG amplitudes) between two groupsTimepoint: Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3 months postoperatively.	—

Secondary

Measure	Time frame
1. To compare change BCVA in patients of two groups. 2. To compare change in choroidal thickness in patients of two groupsTimepoint: Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3 months postoperatively.	—

Countries

India

Contacts

Public ContactAman Kumar

PGIMER, Chandigarh

mankoo95@yahoo.com9463001620

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026