Comparison of retinal architectural changes using intraoperative optical coherence tomography in macular hole surgery- a prospective randomized trial

Completed

Conditions: patients having diabetes mellitus type2, hypertension , hypo/hyperthyroidism were also included

Registration Number: CTRI/2018/05/014219

Lead Sponsor: Dr Rajendra Prasad Center For Ophthalmic Sciences

Brief Summary: macular hole occurs in elderly patients. larger macular hole can be treated surgically only. In this study we have done macular hole surgery with inverted flap ILM peeling technique using intraoperative microscope integrated OCT in 20 patients. we have recruited patients for period of 18 months. Postoperatively patients were followed on 1st day, 1st week,1st month, 3 months, 6 months. Routine inestigations along with OCT were performed in routine followup.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Primary idiopathic macular holes stage 3 and stage 4;Pseudophakic or phakic eyes;No other relevant pathology like AMD, Diabetic maculopathy, trauma etc;Healthy optic nerve.

Exclusion Criteria

Patients with stage 1 and stage 2 macular holes, Traumatic /secondary macular hole and recurrent holes were excluded.
Patients having any macular pathology and previously vitrectomized were not included.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	Visual acuity \| anatomical closure \| postoperative 1st day,1st week,1 month,3months,6 months
anatomical closure	Visual acuity \| anatomical closure \| postoperative 1st day,1st week,1 month,3months,6 months

Secondary Outcome Measures

Name	Time	Method
Distance between Ellipsoid zone and RPE band	postoperatively 1st day,1st 1week, 1st month, 3 months, 6 months

Trial Locations

Locations (1): Dr. Rajendra Prasad Center For Ophthalmic Sciences
🇮🇳
West, DELHI, India
Dr. Rajendra Prasad Center For Ophthalmic Sciences
🇮🇳West, DELHI, India
Lohith Rambarki
Principal investigator
9971532113
lohithmedico06@gmail.com