Post Marketing Clinical Study to Examine the safety and performance of REPER RPR-13 Hydrophobic Intraocular lens.

Prospective single arm, post marketing clinical study of REPER RPR-13 Hydrophobic Intraocular Lens to assess performance and safety in patients undergoing cataract surgery - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/12/078539

Enrollment

Registered

2024-12-24

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

None listed

Interventions

Intervention1: Cataract Surgery: A non-masked randomized controlled clinical trial conducted at a single hospital. patients with age-related cataracts eye were randomly assigned to undergo cataract o

Eligibility

Inclusion criteria

Inclusion criteria: Adults, Subjects who have already undergone cataract surgery using IOL, Calculated IOL power is within the range of the investigational IOL (+ 10.0 to 30.0 Diopter), Subjects available after contact and willing to come for follow up during the clinical study, Subjects with signed informed consent, Subject having clear intraocular media other than cataract.

Exclusion criteria

Exclusion criteria: Patients unwilling to participate in the study, subject with previous intraocular or corneal surgery, Subject having traumatic cataract, Pregnancy or lactation, Concurrent participation in another drug or device investigation, Instability of keratometry or biometry measurements, Irregular astigmatism.

Design outcomes

Primary

Measure	Time frame
To assess the intraoperative safety and performance of the Intraouclar Lens.Timepoint: 2 Months, 6 Months, 12 Months	—

Secondary

Measure	Time frame
To determint the prescence of lens related adverse events, residual risks and visual acuity in the individuals on whom the device was implantedTimepoint: 2 months, 6 months, 1 year	—

Countries

India

Contacts

Public ContactUday Gajiwala

Tejas Eye Hospital

divyajyoti.icare@gmail.com02623221180

Outcome results