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Evaluating the effect of 2 medications that treat glaucoma in patients of early glaucoma.

Evaluating the effect of Dorzolamide vs Netarsudil in Preperimetric and Early Glaucoma- A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064598
Enrollment
90
Registered
2024-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H408- Other glaucoma

Interventions

Intervention1: DORZOLAMIDE: EYEDROP DORZOLAMIDE 2% TDS (THRICE A DAY) FOR 1 MONTH Intervention2: NETARSUDIL: EYEDROP NETARSUDIL 0.02% HS (ONCE A DAY AT NIGHT) FOR 1 YEAR

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 Coexisting retinal disease (for example, diabetic retinopathy) Other diseases affecting visual field Patients on vasodilatory drugs such as Nitroglycerin

Design outcomes

Primary

MeasureTime frame
Vessel Density(ONH AND MACULAR) USING OCTATimepoint: Day 1, 4 months, 8 months, 12 months(if possible)

Secondary

MeasureTime frame
Flux indexTimepoint: Day 1, 4 months, 8 months, 12 months(if possible);Macular Flow IndexTimepoint: Day 1, 4 months, 8 months, 12 months(if possible);pRNFL ThicknessTimepoint: Day 1, 4 months, 8 months, 12 months(if possible);Visual Field ChangesTimepoint: Day 1, 4 months, 8 months, 12 months(if possible)

Countries

India

Contacts

Public ContactDr Vanaja Jain

All India Institute of Medical Sciences

dewang45@gmail.com01126594127

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026