Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
1 other identifier
observational
25
1 country
1
Brief Summary
The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMay 20, 2024
May 1, 2024
4 months
August 25, 2020
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Binocular uncorrected distance, intermediate, and near visual acuity
Through Month one post-op
Binocular uncorrected depth of focus
Through Month one post-op
Secondary Outcomes (5)
Manifest refraction
Through Month one post-op
Monocular uncorrected distance visual acuity
Through Month one post-op
Monocular best corrected distance visual acuity
Through Month one post-op
Visual Satisfaction
Through Month one post-op
4th order total eye spherical aberration (Z12)
Through Month one post-op
Study Arms (1)
Subjects treated with LAL lens
Subjects that underwent standard of care cataract surgery and LAL IOL placement.
Interventions
Standard of care Cataract surgery with IOL placement
Eligibility Criteria
A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.
You may qualify if:
- Patients able to sign informed consent
- Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.
You may not qualify if:
- Inability to sign informed consent
- Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
- Unable to return for light treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 31, 2020
Study Start
September 1, 2020
Primary Completion
January 1, 2021
Study Completion
February 1, 2021
Last Updated
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share