| CTRI Number |
CTRI/2017/05/008663 [Registered on: 25/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between the conventional surgery versus a new surgical technique for treatment of macular holes |
|
Scientific Title of Study
|
Comparative Evaluation Of Conventional Macular Hole Surgery With Inverted Internal Limiting Membrane Flap Technique For Large Macular Holes - A Prospective Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IESC/T-338/23.06.2015 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manasa S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute Of Medical Sciences
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9496768287 |
| Fax |
|
| Email |
sendtomanasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kumar |
| Designation |
Chief, Dr RP Centre and Professor of Ophthalmology |
| Affiliation |
AIIMS |
| Address |
Room no 485
Dr Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute Of Medical Sciences
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126593185 |
| Fax |
|
| Email |
atul56kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasa S |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Dr Rajendra Prasad Centre for Ophthalmic Sciences
All India Institute Of Medical Sciences
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7042284254 |
| Fax |
|
| Email |
sendtomanasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences,
All India Institute of Medical Sciences,
Ansari Nagar
New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
All India Institute Of Medical Sciences
Ansari Nagar
New Delhi
Delhi 110029
N |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manasa S |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
Room no 485,Fourth floor
Dr RP Centre
AIIMS
Ansari Nagar
110029
New Delhi
DELHI |
7042284254
sendtomanasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with large macular holes more than 600 microns, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional macular hole surgery |
Standard macular hole surgery which consist of pars plana vitrectomy and ILM peeling |
| Intervention |
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 place. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Best corrected visual acuity
2.SD-OCT |
Pre operative, at 1 week, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Autofluorescence Imaging
2.Multifocal ERG
3.Microperimetry
4.Fundus photo |
Pre operative, at 1 week,1 month,3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |