Post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus TECNIS EyhanceTM IOL in patients with planned age-related cataract surgery.

A Prospective, randomized, controlled, post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus TECNIS EyhanceTM IOL in patients with planned age-related cataract surgery - EYECRYL_Sert

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/062774

Enrollment

134

Registered

2024-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: EYECRYL Sert : Preloaded monofocal Hydrophobic Aspheric EDOF (Extended depth of focus) lensTotal Expected duration of clinical Study approx 22 months Control Intervention1: TECNIS Eyha

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients having cataract; 2.Female participants of childbearing potential and male participantswhose partner is of childbearing potential must be willing to ensure thatthey or their partner use effective contraception during the study

Exclusion criteria

Exclusion criteria: 1.Systemic disease that could increase the operative risk or confound the outcome 2.Instability of keratometry or biometry measurements and 3.irregular astigmatism

Design outcomes

Primary

Measure	Time frame
To demonstrate that EYECRYL Sert exhibits non inferiority for Distance Corrected Intermediate Visual Acuity (DCIVA) over TECNIS EyhanceTMTimepoint: 1-2days, 7-14 days, 30-60 days, 120-180 days 330-420 day	—

Secondary

Measure	Time frame
To demonstrate that EYECRYL Sert has at least 50% eyes achieving photopic monocular DCIVA 0.2 logMAR or better @ 66cmTimepoint: 120-180 days	—

Countries

India

Contacts

Public ContactMr Bhargav Joshi

Chief Executive Officer

deepaarora@clinexel.com8291351946

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026