To compare and evaluate clinical outcome of three different ophthalmic viscoelastic devices during ophthalmic surgery

A prospective, randomized controlled, open-label, three-arm clinical study to compare and evaluate the clinical outcomes of three different Ophthalmic Viscoelastic devices (OVDs) used during the ophthalmic surgery to protect corneal endothelial cells and maintain anterior chamber space in patientsâ?? eye.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/02/023391

Enrollment

Registered

2020-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: EYEVISCâ?¢ PLUS 2% (Hydroxypropyl Methylcellulose 2%): Sterile non-pyrogenic, viscoelastic preparation of a non-inflammatory, highly purified grade Hydroxypropyl methylcellulose 2% w/v

Eligibility

Inclusion criteria

Inclusion criteria: 1. Unilateral/Bilateral 2. Patients with age >= 45 years. 3. Patients with Grade I to III cataract and used OVDs 4. Patients that have healthy eyes excluding the formation of cataract. 5. A patient who had attended all the regular follow-up examinations as per the routine schedule and follow Protocol Schedule. 6. A patient who are able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Black, Brunescent, traumatic or subluxated cataract. 2. Corneal endothelial disease. 3. Pregnant lady and lactating mother 4. Patient who is part of another device or drug trial. 5. Baseline endothelial cell density 6. Patient who had Glaucoma, Pseudo exfoliation Syndrome with Iris atrophy, Proliferative diabetic retinopathy at the time of surgery. 7. A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis). 8. Previous intra ocular or corneal surgery

Design outcomes

Primary

Measure	Time frame
Endothelial Cell Count Change from Baseline, Intraocular Pressure (IOP) Change from BaselineTimepoint: Time Frame: Pre-operative, 1-day, 2-Week , 1-month, 3-month and 6-months post-surgery Intraocular Pressure (IOP) Change from Baseline	—

Secondary

Measure	Time frame
Investigator Reported Space Maintenance, Change in Corneal thickness in millimeter (mm), Intraocular Inflammation with Grade of Inflammation, Corneal Clarity, CV in cell size in percentage, Cell area in ð???m2, Cell Hexagonality in percentage, Adverse EventsTimepoint: Pre-Operative to 1-day, 2-Week , 1-month, 3-months and 6-months post-surgery	—

Countries

India

Contacts

Public ContactGirish Hirpara

Prasad Netralaya

krishprasadk73@yahoo.com9845102334

Outcome results

None listed

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