AVL200 IOL for Treatment of Cataract and Presbyopia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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 |
Device: AVL200 IOL
The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.
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Outcome Measures
Primary Outcome Measures
- Improvement in monocular best corrected distance visual acuity [Baseline, 3 months postoperative]
Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
Secondary Outcome Measures
- Improvement in monocular distance-corrected near visual acuity [Baseline, 3 months postoperative]
Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
Eligibility Criteria
Criteria
Inclusion Criteria:
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Visually significant cataract
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Best corrected distance visual acuity between 20/40 and 20/200
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Potential distance visual acuity of 20/32 or better
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Corneal astigmatism ≤ 1.5 diopters
Exclusion Criteria:
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Use of medication that could affect accommodation
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Previous corneal surgery or significant corneal abnormalities
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Ocular pathology or degenerative disorder having potential to impair visual acuity
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Pupil abnormality
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Intraoperative cataract surgery complications that could affect IOL implantation or positioning
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Dr Agarwal's Eye Hospital | Chennai | Tamal Nadu | India | 600018 |
Sponsors and Collaborators
- Atia Vision
Investigators
- Principal Investigator: Ashvin Agarwal, MD, Dr. Agarwals Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP100962