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Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

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ClinicalTrials.gov Identifier: NCT04533191
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Vance Thompson Vision

Study Description
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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 disease Intervention/treatment
Cataract Pseudophakia Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 1, 2021
Groups and Cohorts
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Intervention Details:
  • Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision
    Subjects will receive bilateral implantation of a commercially available Light Adjustable Intraocular lens at the time of cataract surgery. Subsequently, they will undergo light adjustment of the lens to target binocular custom vision.

Outcome Measures
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Primary Outcome Measures :
  1. Binocular uncorrected distance, intermediate, and near visual acuity [ Time Frame: Through Month one post-op ]
  2. Binocular uncorrected depth of focus [ Time Frame: Through Month one post-op ]

Secondary Outcome Measures :
  1. Manifest refraction [ Time Frame: Through Month one post-op ]
  2. Monocular uncorrected distance visual acuity [ Time Frame: Through Month one post-op ]
  3. Monocular best corrected distance visual acuity [ Time Frame: Through Month one post-op ]
  4. Visual Satisfaction [ Time Frame: Through Month one post-op ]
    Visual satisfaction will be obtained using a visual questionnaire

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533191


Locations
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United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Keeley Puls    605-371-7075    keeley.puls@vancethompsonvision.com   
Contact: Kristin Dunne    6053613937    kristin.dunne@vancethompsonvision.com   
Sponsors and Collaborators
Vance Thompson Vision
More Information
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Responsible Party: Vance Thompson Vision
ClinicalTrials.gov Identifier: NCT04533191    
Other Study ID Numbers: IIT-001
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cataract
Pseudophakia
Lens Diseases
Eye Diseases