Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Cataract Clinical Trial

Official title:

Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533191
• Other study ID #: IIT-001
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: October 2020
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Pseudophakia

Intervention

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.

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular uncorrected distance, intermediate, and near visual acuity		Through Month one post-op
Primary	Binocular uncorrected depth of focus		Through Month one post-op
Secondary	Manifest refraction		Through Month one post-op
Secondary	Monocular uncorrected distance visual acuity		Through Month one post-op
Secondary	Monocular best corrected distance visual acuity		Through Month one post-op
Secondary	Visual Satisfaction	Visual satisfaction will be obtained using a visual questionnaire	Through Month one post-op
Secondary	4th order total eye spherical aberration (Z12)		Through Month one post-op