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

Phase 4

Recruiting

• Conditions: Unspecified age-related cataract,

• Registration Number: CTRI/2019/04/018671
• Lead Sponsor: BIOTECH VISION CARE PVT LTD

Brief Summary

It is a observational 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.

Total of 140 eyes are to be considered in the study with 70 eyes in each group where  EYECRYL (BIOTECH ) and TECNIS TORIC  implanted into patients .

Patients are recruited according to the inclusion and exclusion criteria mentioned in the study .Enrollment for 9 months and follow up for 6 months

Outcomes of Rotational stability, Refraction, Spherical Equivalence,Intra Ocular Pressure,Change in Endothelial cell count are summarized and compared using statistics.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2020-01-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Rotational Stability,	Pre operatively, day 1,day 15,1,3 and 6 Months.
2.Corrected and Uncorrected Visual Acuity	Pre operatively, day 1,day 15,1,3 and 6 Months.
3.Refraction and Refractive Astigmatism	Pre operatively, day 1,day 15,1,3 and 6 Months.
4.Spherical Equivalence	Pre operatively, day 1,day 15,1,3 and 6 Months.
5.Introcular pressure	Pre operatively, day 1,day 15,1,3 and 6 Months.
6.Change in Endothelial Cell count	Pre operatively, day 1,day 15,1,3 and 6 Months.

Secondary Outcome Measures

Name	Time	Method
Secondary Surgery due to early onset of PCO	3 & 6 Months post surgery

Trial Locations

Locations (1)

CENTRE FOR SIGHT EYE INSTITUTE; 🇮🇳 West, DELHI, India

CENTRE FOR SIGHT EYE INSTITUTE

🇮🇳West, DELHI, India

DR KEYA BARMAN

Principal investigator

9686499992

drkeya.c@gmail.com

DR KIRAN KIRTANI

Principal investigator

08920315341

drkiranp2k@gmail.com