A prospective clinical study to compare the safety and efficacy of three different distance vision correcting water repelling intraocular lenses implanted after cataract surgery

Not yet recruiting

Conditions: Unspecified age-related cataract,

Registration Number: CTRI/2019/08/020754

Lead Sponsor: Biotech healthcare Pvt Ltd

Brief Summary: This is a prospective, randomised, single centre, comparative clinical study to evaluate the safety and efficacy ( visual outcomes, contrast sensitivity and patient satisfaction) of different hydrophobic aspheric monofocal intraocular lenses on patients, 18 years and older, undergoing cataract surgery fulfilling the inclusion criteria and who are willing to participate in the clinical trial. Optiflex genesis, Eyecrylplus ASHFY600 and Tecnis 1 are the three investigational IOLs being used in the study. Sample size of 168 eyes (56 eyes in each arm) considering 20% drop out rate is required to prove the null hypothesis mean change in BCVA for all the three investigational products are same vs the alternative hypothesis of unequal mean change in BCVA.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

age 18 and older Best corrected visual acuity to be 0.2 logmar or lower cataract calculated IOL power within range of investigational IOL subjects are willing and understand and sign informed consent subjects are willing and able to attend postoperative examinations as per schedule.

Exclusion Criteria

previous intraocular and corneal surgery pregnancy and lactation traumatic cataract concurrent participation in another drug or device study chronic uveitis patients receiving chloroquine treatment corneal dystrophy or endothelial insufficiency microphthalmia active ocular diseases( active diabetic retinopathy, uncontrolled glaucoma).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation	Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
Uncorrected visual acuity	Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
best corrected visual acuity	Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
contrast sensitivity	Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up

Secondary Outcome Measures

Name	Time	Method
high order aberrations	manifest refraction

Trial Locations

Locations (1): Nethradhama superspeciality eye hospital
🇮🇳
Bangalore, KARNATAKA, India
Nethradhama superspeciality eye hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Sri Ganesh
Principal investigator
9845129740
phacomaverick@gmail.com