Patient experience and satisfaction and clinical results after PanOptixToric IOL implantation in both eyes of patients undergoing cataract surgery
- Conditions
- Health Condition 1: H00-H59- Diseases of the eye and adnexa
- Registration Number
- CTRI/2020/01/022808
- Lead Sponsor
- ETHRADHAMA SUPER SPECIALITY EYE HOSPITAL BANGALORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Regular corneal topography and corneal astigmatism from 0.75 D to 4.00 D.
2. Best Corrected Visual Acuity to be 0.2 LogMAR or lower
3. Clear intraocular media
4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures
1. Any active ocular disease
2. Diabetic retinopathy, retinal degenerative disorders, macular degeneration, glaucoma with field defects
3. Irregular corneal astigmatism( keratoconus/ PMD)
4. Previous intraocular and corneal refractive surgery
5. Pregnancy & Lactation
6. Traumatic , Intumescent and white Cataracts
7. Subject who have retinal pathologies or dystrophies and those who are expected to require retinal laser treatment
8. Concurrent participation in another drug or device study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: 3 Months post 2nd eye Surgery:- <br/ ><br>Corrected photopic distance visual acuity (CDVA, binocular) <br/ ><br>Timepoint: Pre-opertative/ intra-opera visits and post-operative days 1, 15, 90, 180, 365
- Secondary Outcome Measures
Name Time Method 1. Uncorrected and corrected photopic distance, intermediate and near visual acuity <br/ ><br>2. Improvement in Quality of Life (Quality of Life Questionnaire developed by Rasch Analysis) <br/ ><br>3. Refractive astigmatism <br/ ><br>4. Spherical Equivalent <br/ ><br>5. Binocular Defocus CurveTimepoint: 3 Months post 2nd eye surgery Post-operative visits