NCT04533191CompletedNot Applicable
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vance Thompson Vision
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Binocular uncorrected distance, intermediate, and near visual acuity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Binocular uncorrected distance, intermediate, and near visual acuity
Time Frame: Through Month one post-op
Binocular uncorrected depth of focus
Time Frame: Through Month one post-op
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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