| CTRI Number |
CTRI/2024/08/073023 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| 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
|
Different types of macular hole surgery and its effects on functions of eyes |
|
Scientific Title of Study
|
Comparing the Anatomical and Functional outcome of Total ILM peeling versus Hemi-temporal ILM peeling in Macular Hole surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabha Siddaraju |
| Designation |
DNB trainee |
| Affiliation |
Sankara eye hospital |
| Address |
Department of retina,
Sankara eye hospital,
Kundalahalli gain, Varthur road.
Bangalore - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9606393341 |
| Fax |
|
| Email |
prabhasiddaraju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Ramanjulu |
| Designation |
Consultant |
| Affiliation |
Sankara eye hospital |
| Address |
Department of vitreo- retina surgery
Sankara eye hospital,
Kundalahalli gain, Varthur road.
Bangalore - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9036952706 |
| Fax |
|
| Email |
drragraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabha Siddaraju |
| Designation |
DNB trainee |
| Affiliation |
Sankara eye hospital |
| Address |
Department of retina
Sankara eye hospital,
Kundalahalli gain, Varthur road.
Bangalore - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9606393341 |
| Fax |
|
| Email |
prabhasiddaraju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital
Kundalahalli gate
Varthur main road
Bangalore -560037
Karnataka state
India |
|
|
Primary Sponsor
|
| Name |
Dr Prabha Siddaraju |
| Address |
Sankara eye hospital
Kundalahalli gate
Varthur main road
Bnagalore - 560037 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prabha Siddaraju |
Sanakara eye hospital |
Department of vitreoretinal surgery
Room no- 24 G lounge
Kundalahalli gate
Varthur road
Bangalore - 560037
Bangalore
KARNATAKA |
9606393341
prabhasiddaraju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Sankara eye hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H35||Other retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Macular hole surgery - hemi- temporal ILM peeling |
Hemi-temporal ILM Peeling done in place of 360 degree ILM peeling done and its functional and anatomical outcome is measured till 1st month post op |
| Comparator Agent |
Macular hole surgery- Total ILM peeling |
Conventional 360 degree ILM peeling done and compared its functional and anatomical outcome till 1st month post op |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Idiopathic full thickness macular hole.
2. PPV with ILM peeling - Total peel and Hemi-temporal ILM peeling
3. Tamponading agents of surgeons choice.
4. Quantitative data on our outcome |
|
| ExclusionCriteria |
| Details |
1.Secondary Macular hole due to – MYOPIC, DEGENERATIVE AND TRAUMATIC.
2.Partial thickness macular hole.
3.Other ocular abnormality – glaucoma, ARMD, diabetic retinopathies and retinal vascular disease.
4.Previous vitrectomy for macular holes and with persistent or reopened holes
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Anatomical hole closure between Total ILM peeling v/s Hemi-temporal ILM peeling in macular hole surgery by Fundus photography & En Face OCT/ OCTA |
1 week and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate functional outcome in patients who developed DONFL -
- BCVA
- Humphrey’s 10-2 visual field test.
b) To detect the difference in appearance of DONFL in Total ILM peeling versus Hemi-temporal ILM peeling in Macular Hole surgery by Autofluorescence
c) To study the difference between Retinal thickness in Total ILM peeling versus Hemi-temporal ILM peeling in macular surgery by OCT and OCTA |
1 month post operative period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
07/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/09/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
1.Hemi-temporal ILM peeling is as effective and safe conventional full peeling for macular hole surgery. 2.Complications of ILM peeling alone- Retinal Thinning, DONFL ( dissociation of optic nerve fiber layer) Complications due to dye- chemical trauma. Complications due tamponading agents- Glaucoma, Cataract.
|