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Comparative study between the conventional surgery versus a new surgical technique for treatment of macular holes

Comparative Evaluation Of Conventional Macular Hole Surgery With Inverted Internal Limiting Membrane Flap Technique For Large Macular Holes - A Prospective Randomized Study

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008663
Enrollment
30
Registered
2017-05-25
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- Patients with large macular holes more than 600 microns

Interventions

Intervention1: Inverted ILM flap technique: In inverted ILM flap technique, instead of completely removing the ILM after staining, a remnant attached to the margins of the macular hole was left in pla

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Eyes with large macular holes(more than 600 microns in least diameter) 2.Macular Hole Index less than or equal to 0.4 3.Non traumatic idiopathic holes 4.Phakic/Pseudophakic eyes 5.Informed consent 6.Older than 18 years

Exclusion criteria

Exclusion criteria: 1.Optic disc diseases like glaucoma, AMD and optic atrophy due to other causes 2.Diabetic retinopathy or maculopathy 3.Eyes with retinal detachment 4.Lens opacity or cataract 5.Inability to follow up

Design outcomes

Primary

MeasureTime frame
1.Best corrected visual acuity 2.SD-OCTTimepoint: Pre operative, at 1 week, 1 month and 3 months

Secondary

MeasureTime frame
1.Autofluorescence Imaging 2.Multifocal ERG 3.Microperimetry 4.Fundus photoTimepoint: Pre operative, at 1 week,1 month,3 months

Countries

India

Contacts

Public ContactDr Manasa S

AIIMS

atul56kumar@yahoo.com01126593185

Outcome results

None listed

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