A prospective,randomized comparative clinical study to compare the safety and efficacy of different Hydrophobic Aspheric Monofocal Intraocular lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
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).
Outcomes
Primary Outcomes
To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation
Time Frame: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
Uncorrected visual acuity
Time Frame: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
best corrected visual acuity
Time Frame: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
contrast sensitivity
Time Frame: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
Secondary Outcomes
- high order aberrations(manifest refraction)