Patient satisfaction and quality of vision following implantation of latest technology based Intraocular Lens implantation after cataract surgery in both eyes
- Conditions
- Age-related nuclear cataract,
- Registration Number
- CTRI/2020/08/027105
- Lead Sponsor
- Dr Sri Ganesh
- Brief Summary
Through this study we would like to evaluate the clinical outcomes and quality of vision following bilateral implantation of a new Extended Depth of Focus (EDoF) Intraocular Lens - ZEISS AT LARA 829MP IOL
We would like to assess the spectacle independence for near, intermediate and distant vision.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
A patient with cataract for which phacoemulsification or femtolaser assisted cataract surgery with posterior chamber IOL implantation · Male or female in good general health, 40-80 years of age at the time of the pre-operative examination · A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation · A patient with preoperative corneal astigmatism less than 1D and stable corneal conditions within the last 12 months · A patient with clear ocular media other than cataract in each eye · A patient with normal OCT of the macula in each eye.
- A patient with a known pathology that may affect visual acuity (as determined by the Investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye A patient with amblyopia or strabismus A patient with capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye A patient has a history of significant ocular trauma or prior ocular surgery in either eye A patient with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism (e.g. Keratoconus) A patient that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period in either eye Need for a dioptre out of the range of +16.0D to +26.0D A patient with any uncontrolled systemic disease.
- A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study A patient currently participating or has participated within 30 days prior to the start of this study in a drug or other investigational research study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bilateral,unilateral uncorrected distance visual acuity and Distance corrected visual 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR acuity with ETDRS chart at 4 m 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR Bilateral uncorrected and distance corrected intermediate visual acuity and reading speeds at 60 and 80 cm 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR with Salzburg Reading Desk(SRD) 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR Bilateral uncorrected and distance corrected near vision with ETDRS chart and SRD at 40 cm 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR Defocus curves from +2 to -3 D 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR Contrast sensitivity with CSV 1000 chart. 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR Subjective Questionnare for dysphotopsia and spectacle independence 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR
- Secondary Outcome Measures
Name Time Method Spectacle independence for distance, intermediate and near vision 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR
Trial Locations
- Locations (1)
Nethradhama Superseciality Eye Hospital
🇮🇳Bangalore, KARNATAKA, India
Nethradhama Superseciality Eye Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Sri GaneshPrincipal investigator9845129740phacomaverick@gmail.com