TWO DIFFERENT TORIC IOLS FROM 2 DIFFERENT COMPANIES (TECHNIS AND BIOTECH) WILL BE IMPLANTED AND THEIR FINAL VISUAL OUTCOME WILL BE COMPARED

A PROSPECTIVE,COMPARATIVE RANDOMISED CLINICAL STUDY TO EVALUATE THE SAFETY,EFFICACY AND REFRACTIVE OUTCOME OF TWO DIFFERENT TORIC IOLS IMPLANTED INTO PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM - REFRACTIVE COMPARISION OF TWO TORIC IOLS

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018671

Enrollment

140

Registered

2019-04-18

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: EYECRYL TORIC IOL(BIOTECH VISION CARE PVT.LTD): EFFICACY AND REFRACTIVE OUTCOME OF IMPLANTED BIOTECH EYECRYL TORIC IOL IN PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1 Unilateral 2 Adult patient 3 Best corrected visual acuity projected to be 0.2 logMAR or lower 4 Calculated IOL power is within the range of the investigational IOL 5 Stability of the cornea has been demonstrated by keratometry 6 Expected dilated pupil size at least large enough to visualize the axis markings 7 Corneal cylindrical error within the range defined in the clinical investigation plan 8 Patient must have preoperative regular corneal astigmatism from 0.5 to 4.50 D as per corneal topography or keratometry 9 Patients who have and will attend all follow-up appointments 10 Patients must sign and be given a copy of the written Informed Consent form

Exclusion criteria

Exclusion criteria: 1 Preoperative ocular pathology 2 Presence of irregular corneal astigmatism 3 Ocular co-morbidities affecting visual outcome 4 Previous intra ocular or corneal surgery 5 Traumatic cataract 6 Corneal Opacities 7 Ophthalmic diseases such as pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability 8 Pre-existing corneal astigmatism lesser than 0.75 D 9 Pre-existing retinal disease 10 Pregnant & Lactating women 11 Concurrent participation in another drug or device investigation

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 count Timepoint: Pre operatively, day 1,day 15,1,3 and 6 Months.	—

Secondary

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

Countries

India

Contacts

Public ContactDR KEYA BARMAN

CENTRE FOR SIGHT EYE INSTITUTE

drkeya.c@gmail.com9686499992

Outcome results

None listed

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