| CTRI Number |
CTRI/2025/02/080110 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Flap surgery for hole in important area of retina |
|
Scientific Title of Study
|
Anatomical and functional outcomes after inverse temporal ILM flap technique for macular hole |
| 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 S Kavia |
| Designation |
Post graduate |
| Affiliation |
Sankara Eye hospital Coimbatore |
| Address |
16-ASankara Eye hospital
Shivanandapuram
Sathy road
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9751916663 |
| Fax |
|
| Email |
mail2kavia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M .PRABHU SHANKER |
| Designation |
MBBS DO DNB Fellowship in vitreous retina |
| Affiliation |
Sankara Eye hospital Coimbatore |
| Address |
Sankara Eye hospital
Shivanandapuram
Sathy road
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9443186568 |
| Fax |
|
| Email |
drprabhushanker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Kavia |
| Designation |
Pg student |
| Affiliation |
Sankara Eye hospital Coimbatore |
| Address |
Sankara Eye hospital
Shivanandapuram
Sathy road
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9751916663 |
| Fax |
|
| Email |
mail2kavia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye hospital |
| Address |
Shivanandapuram
Sathy road
Coimbatore -35 |
| 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 S Kavia |
Sankara Eye hospital |
16 A Shivanandapuram
Sathy road
Coimbatore -35
Coimbatore
TAMIL NADU |
09751916663
mail2kavia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H358||Other specified retinal disorders, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Surgical procedure |
Pars plana vitrectomy with posterior vitreous detachment will be done then internal limiting membrane will be stained and flap is made and inverted and tucked into macular hole then fluid gas exchange is performed then patients are asked to maintain prone position for 5 days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with large idiopathic macular hole |
|
| ExclusionCriteria |
| Details |
Prior retinal surgeries
High myopia more than 6D
Increased IOP
Moderate to severe cataract
Age less than 50 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity |
1week 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anatomical closure of macular hole |
1week,1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="2"
Months="6"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The recruited patients are studied for the effectiveness of inverse temporal ILM flap technique surgery by visual outcome and anatomical closure of macular hole |