| CTRI Number |
CTRI/2022/07/044436 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LASER] |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of laser in Glaucoma patients |
|
Scientific Title of Study
|
Outcome of Selective Laser Trabeculoplasty in Primary Open Angle Glaucoma verses Primary Angle Closure Glaucoma in failed Trabeculectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SEJAL SINGLA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVT MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
D BLOCK,LEVEL 3 ,GMCH ,SECTOR32 ,CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8901018922 |
| Fax |
|
| Email |
sejalsingladr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SURESH KUMAR |
| Designation |
HEAD OF DEPARTMENT ,OPHTHALMOLOGY |
| Affiliation |
GOVT MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
D BLOCK,LEVEL 3 ,GMCH ,SECTOR32 ,CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SURESH KUMAR |
| Designation |
HEAD OF DEPARTMENT ,OPHTHALMOLOGY |
| Affiliation |
Department of opnthalmology, gmch,chandigarh |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
D BLOCK,LEVEL 3 ,GMCH ,SECTOR32 ,CHANDIGARH
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF OPHTHALMOLOGY |
| Address |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL,SECTOR 32,CHANDIGRH |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gmch |
sector32,chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sejal singla |
GMCH,chandigarh |
sector 32 Chandigarh
Department of ophthalmology, Chandigarh
level IV, B block
Chandigarh
CHANDIGARH |
8901018922
sejalsingladr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS CORE COMMITTEE(GMCH,CHANDIGARH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
selective laser trabeculoplasty |
selective laser trabeculoplasty in POAG and PACG ,one time - frequency
5-10 minutes duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
HAVE UNDERGONE TRABECULECTOMY,BUT FAILED TO ATTAIN TARGET IOP DESPITE MORE THAN 2 ANTIGLAUCOMA DRUGS TAKEN FOR ATLEAST 3 MONTHS
2. NOT PLAN TO BECOME PREGNANT DURING TREATMENT
3 180 ANGLE SHOULD BE OPEN IN PACG PATIENTS
4 SHOULD NOT UNDERGO ANY OCULAR SURGERY TILL 3 MONTHS AFTER SLT |
|
| ExclusionCriteria |
| Details |
SYSTEMIC OR OCULAR DISEASE REQUIRING TOPICAL AND ORAL CORTICOSTEROID THERAPY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INTRAOCULAR PRESSURE AFTER SLT |
2 WEEKS, 6 WEEKS, 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN ANTIGLAUCOMA DRUGS AFTER SLT |
2 WEEKS, 6 WEEKS, 12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim is to study outcome of Selective Laser Trabeculoplasty in primary open angle glaucoma verses primary angle closure glaucoma in patients with failed Trabeculectomy. |