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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVL200 IOL | Experimental | The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVL200 IOL | Device | The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monocular best corrected distance visual acuity | Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in monocular distance-corrected near visual acuity | Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart | 3 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashvin Agarwal, MD | Dr. Agarwals Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Agarwal's Eye Hospital | Chennai | Tamal Nadu | 600018 | India |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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