| CTRI Number |
CTRI/2024/11/076951 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Laser Treatment] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Laser treatment in Glaucoma |
|
Scientific Title of Study
|
Effectiveness of selective laser trabeculoplasty (SLT) vs topical anti glaucoma medications in early primary open angle glaucoma and ocular hypertension (OHT) as first line treatment
|
| 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 Ramya K |
| Designation |
Fellow Resident Glaucoma |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
2E-806,Provident Park Square,
Judicial Layout, Kanakapura Rd
Department of Glaucoma,256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560109
India |
| Phone |
|
| Fax |
|
| Email |
ramyamohan412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha M S |
| Designation |
Senior Glaucoma Consultant |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Annapurna, No.408, 12th Cross
Road, Upper Palace Orchards, Sadashivanagar, Bangalore-560080
Bangalore
KARNATAKA
560080
India |
| Phone |
9845373709 |
| Fax |
|
| Email |
drashamag@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha M S |
| Designation |
Senior Glaucoma Consultant |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Annapurna, No.408, 12th Cross
Road, Upper Palace Orchards, Sadashivanagar, Bangalore-560080
Bangalore
KARNATAKA
560080
India |
| Phone |
9845373709 |
| Fax |
|
| Email |
drashamag@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070 |
|
|
Primary Sponsor
|
| Name |
Dr Ramya K |
| Address |
2E-806
Provident Park Square,
Judicial Layout,
Kanakapura Rd,
Bengaluru, Karnataka
Pin: 560109 |
| 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 Asha M S |
Nethradhama Super Speciality Eye Hospital |
256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9845373709
drashamag@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Super Speciality Eye Hospital Institutional Ethics Committee |
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 |
Laser trabeculoplasty and anti glaucoma drops |
To one group providing laser procedure and topical anti glaucoma drops to other group |
| Intervention |
Selective Laser Trabeculoplasty (SLT) and topical anti glaucoma medications |
For early primary open angle glaucoma and ocular hypertension (OHT) as first line treatment - 6 months study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Early primary open-angle glaucoma (POAG)-Not on any anti glaucoma medications
Ocular Hypertension (≥23 mmHg on 2 consecutive measurements)Â
|
|
| ExclusionCriteria |
| Details |
Not willing to participate
Patients with h/o prior intra ocular surgery except cataract surgery
Moderate to advanced primary open angle glaucoma
Congenital, childhood glaucomas
Secondary glaucomas
Patients with occludable/closed angles in gonioscopy
Unable to use topical AGM
With any contraindications for SLT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in intra ocular pressure |
1 week and 1, 3, 6 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce progression in visual field defects |
3 and 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
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
|
This is an institution based comparative interventional study. The primary objective is to compare the efficacy of selective laser trabeculoplasty (SLT) vs Topical Anti Glaucoma drops in lowering intraocular pressure (IOP) as initial treatment in patients with early primary open-angle glaucoma (POAG)and Ocular Hypertension (OHT). |