AVL200 IOL for Treatment of Cataract and Presbyopia
Not Applicable
Recruiting
- Conditions
- Cataract
- Interventions
- Device: AVL200 IOL
- Registration Number
- NCT05627700
- Lead Sponsor
- Atia Vision
- Brief Summary
This study is to evaluate the performance of the AVL200 IOL in terms of visual function improvement over a range of focal points. Participants meeting eligibility criteria will undergo cataract surgery with implantation of the AVL200 intraocular lens (IOL), then be followed through 1 year postoperatively. Postoperative assessments include safety and visual function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Visually significant cataract
- Best corrected distance visual acuity between 20/40 and 20/200
- Potential distance visual acuity of 20/32 or better
- Corneal astigmatism ≤ 1.5 diopters
Exclusion Criteria
- Use of medication that could affect accommodation
- Previous corneal surgery or significant corneal abnormalities
- Ocular pathology or degenerative disorder having potential to impair visual acuity
- Pupil abnormality
- Intraoperative cataract surgery complications that could affect IOL implantation or positioning
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVL200 IOL AVL200 IOL The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points
- Primary Outcome Measures
Name Time Method Change in monocular best corrected distance visual acuity 3 months postoperative Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
- Secondary Outcome Measures
Name Time Method Change in monocular distance-corrected near visual acuity 3 months postoperative Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
Trial Locations
- Locations (1)
Dr Agarwal's Eye Hospital
🇮🇳Chennai, Tamal Nadu, India