Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

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

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 Disease	Intervention/Treatment	Phase
Cataract; Pseudophakia	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

	Site	City	State	Country	Postal Code
1	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

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: Cataract; Pseudophakia

Study Results

No Results Posted as of Oct 8, 2020