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

A prospective,randomized comparative clinical study to compare the safety and efficacy of different Hydrophobic Aspheric Monofocal Intraocular lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020754
Enrollment
168
Registered
2019-08-19
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: Optiflex Genesis hydrophobic aspheric monofocal intraocular Lens: Implantation of Optiflex genesis,a hydrophobic aspheric monofocal lens in patients undergoing cataract surgery and eval

Sponsors

Biotech healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
high order aberrations manifest refraction defocus curve corrected upto 4D fundus visualisation PCO IOP IOL discolouration adverse eventTimepoint: pre-op, intra op, 1,7, 30,90,180 and 365 days follow up

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama superspeciality eye hospital

phacomaverick@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026