To compare and evaluate the safety, efficacy and refractive outcome of three different Hydrophilic Monofocal Intraocular Lens implanted to cataract patients.

A prospective, comparative, randomized clinical study to compare and evaluate the safety, efficacy and refractive outcome of three different Hydrophilic Monofocal Intraocular Lens implanted to cataract patients. - BTVCPL-HFIOL-2019-02

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022318

Enrollment

138

Registered

2019-12-11

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: H259- Unspecified age-related cataract

Interventions

Intervention1: EYECRYLÂ® Plus 600: Hydrophilic single piece, injectable, Spherical Monofocal Intraocular Lens Intervention2: Eyecryl Plus HSAS600: Hydrophobic surface, Hydrophilic Aspheric Monofocal I

Eligibility

Inclusion criteria

Inclusion criteria: 1. Unilateral/Bilateral Cataract 2. Patients with age > 50 years. 3. Patients with Grade I or Grade II cataract as per Lens Opacities Classification System III (LOCS-III). 4. Patients that have healthy eyes excluding the formation of senile cataract. 5. Patient who are ready to attended all the regular follow-up examinations as per the routine schedule.

Exclusion criteria

Exclusion criteria: 1. Patients receiving Chloroquine treatment. 2. Preoperative corneal astigmatism > 1. 3. Baseline endothelial cell density 4. Amblyopia, Microphthalmia, Glaucoma, Pseudoexfoliation Syndrome with Glaucoma, Iris atrophy, Proliferative diabetic retinopathy and all retinal pathologies. 5. A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, Iridocyclitis, rubeosis iritis). 6. Previous intra-ocular or corneal surgery. 7. Pregnant or lactating mother. 8. Concurrent participation in another drug or device Study

Design outcomes

Secondary

Measure	Time frame
(1) Intraocular Pressure (2) Change in Endothelial cell count (3) Fundus Visualization (4) PCO Timepoint: Pre-op, 15 days, 1, 3, 6 & 12 Months post-surgery	—

Primary

Measure	Time frame
(1) Visual Acuity (2) Refraction (3) Spherical EquivalentTimepoint: Pre-op, 15 days, 1, 3, 6 & 12 Months post-surgery	—

Countries

India

Contacts

Public ContactDr Subodh Sinha

CENTRE FOR SIGHT EYE INSTITUTE

drsubodhsinha@gmail.com9810789986

Outcome results

None listed

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