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

Phase 1/2

Completed

Conditions: Patients with large macular holes more than 600 microns

Registration Number: CTRI/2017/05/008663

Lead Sponsor: Dr Rajendra Prasad Centre for Ophthalmic Sciences

Brief Summary: Large macular holes usually have an increased risk of failure. Flat open macular holes are associated with limited visual acuity. This study compares conventional macular hole surgery with inverted Internal Limiting Membrane Flap technique in patients with large macular holes. Study design will be a prospective comparative study. Patients with macular holes larger than 600 microns will be included . In group 1 15 eyes will undergo standard 3 port pars plana vitrectomy with air and in group 2 15 eyes will undergo inverted ILM flap technique. Primary outcome measures are best corrected visual acuity and post operative macular hole closure , Investigations will de bone pre operatively and on follow up at 1 week, 1 month,3 months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Best corrected visual acuity	Pre operative, at 1 week, 1 month and 3 months
2.SD-OCT	Pre operative, at 1 week, 1 month and 3 months

Secondary Outcome Measures

Name	Time	Method
1.Autofluorescence Imaging	2.Multifocal ERG

Trial Locations

Locations (1): Dr Rajendra Prasad Centre for Ophthalmic Sciences
🇮🇳
Delhi, DELHI, India
Dr Rajendra Prasad Centre for Ophthalmic Sciences
🇮🇳Delhi, DELHI, India
Dr Manasa S
Principal investigator
7042284254
sendtomanasa@gmail.com