A Clinical Study to check the safety and effectiveness of AVL200 Modular Intraocular Lens.
Not Applicable
Completed
- Conditions
- Health Condition 1: H258- Other age-related cataract
- Registration Number
- CTRI/2023/05/052664
- Lead Sponsor
- ATIA VISION,INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1)Visually significant cataract.
2)Best corrected distance visual acuity between 20/40 and 20/200.
3)Corneal astigmatism <= 1.5 diopters.
4)Potential distance visual acuity of 20/25 or better.
Exclusion Criteria
1)Uncontrolled systemic disease that could increase operative risk or confound outcome.
2)Use of medication that could affect accommodation.
3)Previous corneal surgery or significant corneal abnormalities.
3)Ocular pathology or degenerative disorder having potential to impair visual acuity.
4)Pupil abnormality.
5)Intraoperative cataract surgery complications that could affect IOL implantation or positioning.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Uncorrected distance visual acuity (UCDVA) â?? monocular and binocular. <br/ ><br>2)Uncorrected intermediate visual acuity (UCIVA) â?? monocular and binocular. <br/ ><br>3) Uncorrected distance visual acuity (UCDVA) â?? monocular and binocular. <br/ ><br>4)Distance-corrected intermediate visual acuity (DCIVA) â?? monocular and binocular. <br/ ><br>5)Distance-corrected near visual acuity (DCNVA) â?? monocular and binocular.Timepoint: Post-Operation Month 1,3,6,12 and 36. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)Ocular adverse events (AE) <br/ ><br>2)Secondary surgical interventions related to design characteristics of the AVL200 IOL System <br/ ><br>3)Best-corrected distance visual acuity (BCDVA) â?? monocular and binocular <br/ ><br>4)Far contrast sensitivity (mesopic, with and without glare) <br/ ><br>5)Intraocular pressure (IOP) <br/ ><br>6)Endothelial cell density (ECD) <br/ ><br>Timepoint: Throughout the study, i.e., Post Op Day 1, Week 1, Month 1, 3, 6 and 12.