Back to resultsAVL200 IOL for Treatment of Cataract and Presbyopia
Primary Purpose
Cataract
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
AVL200 IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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
Sites / Locations
- Dr Agarwal's Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AVL200 IOL
Arm Description
The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627700
Brief Title
AVL200 IOL for Treatment of Cataract and Presbyopia
Official Title
A Prospective, Open-label, Single-center Study of the Atia™ AVL200 Modular Intraocular Lens System for Treatment of Cataract and Presbyopia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atia Vision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AVL200 IOL
Arm Type
Experimental
Arm Description
The AVL200 is a modular fluid-filled, shape-changing intraocular lens (IOL) designed to restore visual function across a range of focal points
Intervention Type
Device
Intervention Name(s)
AVL200 IOL
Intervention Description
The AVL200 is an intraocular lens surgically implanted in the eye after cataract surgery.
Primary Outcome Measure Information:
Title
Change in monocular best corrected distance visual acuity
Description
Best-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
Time Frame
3 months postoperative
Secondary Outcome Measure Information:
Title
Change in monocular distance-corrected near visual acuity
Description
Distance-corrected distance visual acuity as measured using an early-treatment diabetic retinopathy study (ETDRS) eye chart
Time Frame
3 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Guerrero
Phone
408-560-3339
Email
melissa@atiavision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Preethi Thiagarajan, OD
Email
preethi@atiavision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashvin Agarwal, MD
Organizational Affiliation
Dr. Agarwals Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Agarwal's Eye Hospital
City
Chennai
State/Province
Tamal Nadu
ZIP/Postal Code
600018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
044 4300 8800
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AVL200 IOL for Treatment of Cataract and Presbyopia
We'll reach out to this number within 24 hrs