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Inverted Internal limiting membrane (ILM) flap technique versus ILM peeling for treatment of large macular holes: A Randomised Control Trial

Comparative study of inverted ILM flap technique over standard technique in large macular holes

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010474
Enrollment
50
Registered
2017-11-13
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: null- Large Macular hole in retina of the eye

Interventions

Intervention1: Dr Naresh Babu: Senior Medical Consultant, Department of Vitreo-retinal services, Aravind Eye Hospital, MAdurai, Tsmil Nadu Intervention2: Inverted Internal limiting membrane (ILM) flap
Ocublue plus, Aurolab, India mixed with 10% dextrose in 1:2 proportions). HBBG was injected slowly under saline and washed immediately. The stained ILM was pinched with a 25G end dripping forceps (Gri
Synergetics, Inc., OFallon, MO, USA). Fluidâ??air exchange (FAE) was done multiple times to ensure complete fluid removal. The superonasal and superotemporal cannulae were then removed and the conjunc

Sponsors

Aravind Eye Hospital and Post graduate and Institute of Ophthalmology Madurai Tamil Nadu India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with idiopathic full thickness macular hole with a minimum diameter exceeding 600μm

Exclusion criteria

Exclusion criteria: Patients with minimum hole diameter exceeding 1500μm, traumatic macular holes, myopic macular holes, other co-existing ocular pathologies affecting vision and those refusing randomization

Design outcomes

Primary

MeasureTime frame
Anatomical outcome. Anatomical success was defined as Type 1 anatomical closure i.e flattening of macular hole with resolution of subretinal cuff of fluid and neurosensory retina (NSR) completely covering the fovea.Timepoint: 1 month and 6 months

Secondary

MeasureTime frame
Visual outcome, which was defined as the gain in visionTimepoint: 1 month and 6 months

Countries

India

Contacts

Public ContactDr Naresh Babu

Department of Vitreo-retinal services, Aravind Eye Hospital, Madurai

cauveryeye@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026