Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Completed

• Conditions: Cataract; Pseudophakia
• Interventions: Procedure: LAL IOL lens

• Registration Number: NCT04533191
• Lead Sponsor: Vance Thompson Vision

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-31
• Study Start: 2020-09-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with LAL lens	LAL IOL lens	Subjects that underwent standard of care cataract surgery and LAL IOL placement.

Primary Outcome Measures

Name	Time	Method
Binocular uncorrected distance, intermediate, and near visual acuity	Through Month one post-op
Binocular uncorrected depth of focus	Through Month one post-op

Secondary Outcome Measures

Name	Time	Method
Manifest refraction	Through Month one post-op
Monocular best corrected distance visual acuity	Through Month one post-op
Visual Satisfaction	Through Month one post-op	Visual satisfaction will be obtained using a visual questionnaire
Monocular uncorrected distance visual acuity	Through Month one post-op
4th order total eye spherical aberration (Z12)	Through Month one post-op

Trial Locations

Locations (1)

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States