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 Applicable
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2019/08/020754
- Lead Sponsor
- Biotech healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <br/ ><br>Uncorrected visual acuity <br/ ><br>best corrected visual acuity <br/ ><br>contrast sensitivityTimepoint: Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up
- Secondary Outcome Measures
Name Time Method high order aberrations <br/ ><br>manifest refraction <br/ ><br>defocus curve corrected upto 4D <br/ ><br>fundus visualisation <br/ ><br>PCO <br/ ><br>IOP <br/ ><br>IOL discolouration <br/ ><br>adverse eventTimepoint: pre-op, intra op, 1,7, 30,90,180 and 365 days follow up