| CTRI Number |
CTRI/2024/03/064598 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effect of 2 medications that treat glaucoma in patients of early glaucoma. |
|
Scientific Title of Study
|
Evaluating the effect of Dorzolamide vs Netarsudil in Preperimetric and Early Glaucoma- A Randomised Controlled Trial |
| 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 Dewang Angmo |
| Designation |
Associate Professor of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr.Rajendra Prasad Centre for Ophthalmic Sciences, All India
Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
01126594127 |
| Fax |
|
| Email |
dewang45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dewang Angmo |
| Designation |
Associate Professor of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
ROOM 374, 3RD FLOOR,
Dr.Rajendra Prasad Centre for Ophthalmic Sciences, All India
Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
01126594127 |
| Fax |
|
| Email |
dewang45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanaja Jain |
| Designation |
Postgraduate |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr.Rajendra Prasad Centre for Ophthalmic Sciences, All India
Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
9815311558 |
| Fax |
|
| Email |
vanajajain25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS Campus Temple, Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
Ansari Nagar, New Delhi |
| 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 |
| Dr Dewang Angmo |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
AIIMS Campus Templa, Ansari Nagar East, New Delhi, Delhi 110016
South
DELHI |
01126594127
dewang45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H408||Other glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DORZOLAMIDE |
EYEDROP DORZOLAMIDE 2% TDS (THRICE A DAY) FOR 1 MONTH |
| Intervention |
NETARSUDIL |
EYEDROP NETARSUDIL 0.02% HS (ONCE A DAY AT NIGHT) FOR 1 YEAR |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Preperimetric Glaucoma-
Age over 40 years
Open angle in gonioscopy
Baseline IOP ≤ 25mmHg
Best-corrected visual acuity 20/40 or better (refractive error ± 5.0D spherical; ± 3.0D cylinder)
Abnormal circumpapillary RNFL thickness (cpRNFLT) in at least one quadrant on OCT scan
A visual field within the normal limits of a glaucoma hemifield test, with pattern standard deviation (PSD) greater than 5%, confirmed in at least two examinations
Early Glaucoma-
BCVA 20/40 or more (refractive error ± 5.0D spherical; ± 3.0D cylinder)
Open angles on gonioscopy
Baseline IOP ≤ 25mmHg
Features suggestive of glaucomatous optic neuropathy such as cup‑disc ratio >0.6 and any diffuse or focal neuroretinal rim thinning 2 consecutive abnormal visual field tests defined as PSD outside 95% normal confidence limits and a GHT classified as ‘‘outside normal limits’’ as defined by the Hodapp-Parrish-Anderson (HPA) criteria for early glaucoma
|
|
| ExclusionCriteria |
| Details |
Patients with moderate or advanced glaucoma (MD worse than ‑6 dB)
Patients with media opacity precluding good‑quality OCT scans such as corneal opacity, cataracts, etc.
History of intraocular diseases, complicated intraocular surgery, secondary glaucoma
Age< 40 years
Coexisting retinal disease (for example, diabetic retinopathy)
Other diseases affecting visual field
Patients on vasodilatory drugs such as Nitroglycerin
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vessel Density(ONH AND MACULAR) USING OCTA |
Day 1, 4 months, 8 months, 12 months(if possible) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Macular Flow Index |
Day 1, 4 months, 8 months, 12 months(if possible) |
| pRNFL Thickness |
Day 1, 4 months, 8 months, 12 months(if possible) |
| Visual Field Changes |
Day 1, 4 months, 8 months, 12 months(if possible) |
| Flux index |
Day 1, 4 months, 8 months, 12 months(if possible) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neuroprotective therapy which delay neurodegeneration can be used to halt disease progression in patients of preperimetric/early glaucoma
Dorzolamide (1994) is known to improve microcirculation in the optic nerve head and thus have a role in neuroprotection. Netarsudil (2018) is a newly launched drug in glaucoma armamentarium, which not only lowers IOP but also improves ocular blood flow and promotes RGC survival Hence, we plan to compare the effect of Dorzolamide and Netarsudil on OCTA vessel density in preperimetric /early glaucoma patients. .
|