Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Sponsor
Vance Thompson Vision (Other)
Overall Status
Recruiting
CT.gov ID
NCT04533191
Collaborator
(none)
25
Enrollment
1
Location
5
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Binocular uncorrected distance, intermediate, and near visual acuity [Through Month one post-op]

  2. Binocular uncorrected depth of focus [Through Month one post-op]

Secondary Outcome Measures

  1. Manifest refraction [Through Month one post-op]

  2. Monocular uncorrected distance visual acuity [Through Month one post-op]

  3. Monocular best corrected distance visual acuity [Through Month one post-op]

  4. Visual Satisfaction [Through Month one post-op]

    Visual satisfaction will be obtained using a visual questionnaire

  5. 4th order total eye spherical aberration (Z12) [Through Month one post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Patients able to sign informed consent

  2. 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Vance Thompson VisionSioux FallsSouth DakotaUnited States57108

Sponsors and Collaborators

  • Vance Thompson Vision

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vance Thompson Vision
ClinicalTrials.gov Identifier:
NCT04533191
Other Study ID Numbers:
  • IIT-001
First Posted:
Aug 31, 2020
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2020