| CTRI Number |
CTRI/2019/07/020381 [Registered on: 26/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Macular hole surgery using internal limiting membrane peeling using a novel technique |
|
Scientific Title of Study
|
Limited versus Conventional Internal limiting
membrane peeling in Macular hole surgery –
Structural and functional outcome
comparison |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aman Kumar |
| Designation |
Junior resident Ophthalmology |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced Eye Centre, PGIMER, Chandigarh- 160012
D-66 Malcha Marg, Chanakya Puri, New Delhi- 110021
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9999970392 |
| Fax |
|
| Email |
aman123kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramandeep Singh |
| Designation |
Professor of Ophthalmology |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced Eye Centre, PGIMER, Chandigarh - 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9463001620 |
| Fax |
|
| Email |
mankoo95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aman Kumar |
| Designation |
Junior resident Ophthalmology |
| Affiliation |
Advanced Eye Centre, PGIMER Chandigarh |
| Address |
Advanced Eye Centre, PGIMER, Chandigarh - 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9999970392 |
| Fax |
|
| Email |
aman123kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Eye Centre, PGIMER Chandigarh- 160012 |
|
|
Primary Sponsor
|
| Name |
Advanced Eye Centre |
| Address |
PGIMER, Chandigarh, 160012 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| AMAN KUMAR |
PGIMER Chandigarh |
Advanced Eye Centre, Office Room No. 118.
Chandigarh
CHANDIGARH |
9999970392
aman123kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pars Plana Vitrectomy with ILM peeling |
After detailed consent, three standard pars plana ports will be made
with continuous infusion running through the inferotemporal port. Core vitrectomy will be
done with cutter followed by peripheral shave vitrectomy. Triamcinolone acetonide will be
used to delineate the left over strands and the presence the posterior vitreous cortex
attachment. A complete posterior vitreous cortex detachment will be induced and vitrectomy
will be completed. Brilliant blue B dye will be injected; the excess dye will be removed after
using active suction. An internal limiting membrane will be grasped with Eckardt ILM
forceps and will be peeled off depending on the randomisation. 360 degree ILM peeling around the
macular area will be
done. Fluid air exchange will be done followed by internal tamponade with 20%
SF6 gas. Topical antibiotics, steroids and cycloplegics will be given postoperatively.
All patients will be given prone posture for first 72 hours of postoperative period.Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3
months postoperatively. |
| Comparator Agent |
Pars plana Vitrectomy with Papillomacular bundle sparing ILM peeling |
After detailed consent, three standard pars plana ports will be made
with continuous infusion running through the inferotemporal port. Core vitrectomy will be
done with cutter followed by peripheral shave vitrectomy. Triamcinolone acetonide will be
used to delineate the left over strands and the presence the posterior vitreous cortex
attachment. A complete posterior vitreous cortex detachment will be induced and vitrectomy
will be completed. Brilliant blue B dye will be injected; the excess dye will be removed after
using active suction. An internal limiting membrane will be grasped with Eckardt ILM
forceps and will be peeled off depending on the randomisation. Limited ILM peeling (sparing papillomacular bundle) will be
done. Fluid air exchange will be done followed by internal tamponade with 20%
SF6 gas. Topical antibiotics, steroids and cycloplegics will be given postoperatively.
All patients will be given prone posture for first 72 hours of postoperative period.Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3
months postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 50 years of age and of any gender
2. Patients either pseudophakic or phakic having primary idiopathic macular holes stage 3 and stage 4 with healthy optic nerve.
3. Macular hole of size less than 400 microns |
|
| ExclusionCriteria |
| Details |
1. Inability to maintain postoperative position
2. Previous ocular surgery
3. Traumatic macular holes
4. No other ocular disease apart from Macular hole such as glaucoma, corneal opacity and significant cataract
5. Media opacity not allowing good quality OCT scans
• The patients were explained the study and consent process and the prospective participant were invited to take part in the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare structural outcome (Hole Closure) between two groups.
2. To compare functional outcome (Changes in Retinal thickness, RNFL thickness,
macular ganglion cell layer thickness and mf ERG amplitudes) between two groups |
Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3
months postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare change BCVA in patients of two groups.
2. To compare change in choroidal thickness in patients of two groups |
Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3
months postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
ILM peeling in macular hole surgery is done in macular area including the papillomacular bundle. Since, papillomacular bundle carries the most crucial nerve fibres from fovea to disc. We hypothesize that if we can avoid ILM peeling over the papillomacular bundle, we may be able to prevent damage to the papillomacular bundle. However, less ILM peeling may result in low closure rate. It has been shown that larger ILM peeled area causes greater reduction of clinical symptoms of the patient.14 In this study, we plan to analyse structural and functional outcome in patients of FTMH undergoing macular hole surgery using two techniques of BBG dye assisted ILM peeling i.e. conventional in one group and limited (sparing ILM over the papillomacular bundle in the second group. |