CLINICAL OUTCOMES OF DIFFERENT MULTIFOCAL TORIC IOLs IN ONE YEAR PROSPECTIVE CLINICAL STUDY
Not yet recruiting
- Conditions
- Unspecified age-related cataract,
- Registration Number
- CTRI/2019/10/021676
- Lead Sponsor
- Dr Sri Ganesh
- Brief Summary
This is a Prospective, comparative clinical study of 2 different Multifocal Toric IOLs i.e, Eyecryl ACTV Diffractive Multifocal IOL and TECNIS Multifocal Toric with 3.25 near addition
It is a single centre study for 1 year duration. 64 Subjects(128 eyes)-32 subject(64 eyes) in each arm will be taken.
The primary objective of this clinical study is to characterize and compare the safety and effectiveness of these 2 Multifocal Toric IOLs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Patients who has been implanted bilaterally with the Multifocal Toric IOL will be included in the Study.
- Age 18 and older 3.
- Regular corneal topography and corneal astigmatism more than 0.75 D.
- Best Corrected Visual Acuity to be 0.2 LogMAR or Lower 5.
- Clear intraocular media 6.
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures 7.
- Patients who has given informed written consent.
Exclusion Criteria
- Any active ocular disease (Diabetic retinopathy, macular degeneration, glaucoma with field defects and irregular corneal astigmatism) 2.
- Previous intraocular and corneal surgery 3.
- Pregnancy & Lactation 4.
- Traumatic Cataract 5.
- Subject who are expected to required retinal laser treatment Concurrent participation in another drug or device Study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual acuity (UCDVA & BCDVA).Visual acuity (Near & Intermediate).Toric Marks Measurement (Rotational Stability) using Itrace.Refractive astigmatism.Spherical Equivalent Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days
- Secondary Outcome Measures
Name Time Method Intraocular Pressure (IOP).Endothelial Cell Count.Pupil Size.Defocus CurveCorrected up to ± 4 D. Preoperative Visit.Intraoperative Visit.Postoperative 1 Day.Postoperative 7 Days.Postoperative 30 Days.Postoperative 90 Days.Postoperative 180 Days.Postoperative 365 Days
Trial Locations
- Locations (1)
Nethradhama Super Speciality Eye Hospital
🇮🇳Bangalore, KARNATAKA, India
Nethradhama Super Speciality Eye Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Sri GaneshPrincipal investigator9845129740phacomaverick@gmail.com