Two different toric IOLs from 2 different companies will be implanted and their final visual outcomes will be compared.

A prospective, comparative, randomized post-marketing clinical study to evaluate the safety, efficacy and refractive outcome of two different toric Intraocular Lens implanted into patients with cataract and corneal astigmatism. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064570

Enrollment

276

Registered

2024-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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: EYECRYL TORIC IOL(BIOTECH VISION CARE PVT.LTD): Total duration of study is 24 months. frequency of study is as below Patients will be followed-up for following schedule: ? Visit 0-Pre

Eligibility

Inclusion criteria

Inclusion criteria: Unilateral and Bilateral Implantation BCVA to be 0.2 Log Mar or Lower Power withing the range of Investigational IOL Stability of the cornea Patients who have and will attend all follow-up appointments Patients must sign and be given a copy of the written Informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preoperative ocular pathology 2. Ocular co-morbidities affecting visual outcome 3. Previous intra ocular or corneal surgery 4. Traumatic cataract 5. Corneal Opacities 6. Irregular astigmatism 7. instability of keratometry or biometry measurements; 8. Ophthalmic diseases such as Pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability

Design outcomes

Primary

Measure	Time frame
1. Rotational Stability, 2. Corrected and Uncorrected Visual Acuity 3. Refraction and Refractive Astigmatism 4. Spherical Equivalence 5. Introcular pressure 6. Change in Endothelial Cell countTimepoint: ? Visit 1- Post-operative Day 1-2 ? Visit 2- Post-operative Day 7-14 ? Visit 3- Post-operative Day 30-60 ? Visit 4- Post-operative Day 120 to 180 ? Visit 5-Post-operative Day 330 to 42	—

Secondary

Measure	Time frame
Secondary Surgery due to early onset of PCOTimepoint: 3, 6 & 12 Months post surgery	—

Countries

India

Contacts

Public ContactDr Samar Kumar Basak

Disha eye Hospitals

basak_sk@hotmail.com03366360000

Outcome results

None listed

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