Safety and efficacy of Supraphob Regen T lens.

To Evaluate the Safety and Efficacy of Supraphob Regen T IOL of Appasamy Ocular Devices Pvt.Ltd implanted Bilaterally in Adults undergoing Cataract Surgery upto 1 Year post implantation. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078016

Enrollment

Registered

2024-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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: Appasamy supraphob t regen IOL: Appasamy Intervention2: Appasamy ocular devices pvt.ltd: Intraocular lens Control Intervention1: Appasamy ocular devices pvt.ltd: N/a

Eligibility

Inclusion criteria

Inclusion criteria: Subjects agreeing to and eligible for bilateral implantation with IMD within 30 days of first implantation Subjects with catarct that is amenable for extraction by phacoemulsification and implantation of iol Subjects with clear intraocular media other than cataract

Exclusion criteria

Exclusion criteria: Subjects with instabilty of keratometry or biometry measurements Subjects with macular degeneration,disease or retinopathy,neuro-ophthalmic diseases Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol

Design outcomes

Primary

Measure	Time frame
Visual improvement for distance intermediate near visual acuityTimepoint: After 4 weeks and 8 weeks	—

Secondary

Measure	Time frame
Synaptophore Contrast sensitivity Best corrected visual acuity for distance , intermediate & nearTimepoint: After 4 weeks & 8 weeks	—

Countries

India

Contacts

Public ContactDr Rajesh Sinha

Dr.R.P.Centre for Ophthalmic Sciences

sinharaj1@gmail.com9868937900

Outcome results

None listed

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