Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)

NCT06488066 | Withdrawn FDA Device

• 1 other identifier: IIT-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).

Conditions

Cataract; Pseudophakia

Outcome Measures

Primary Outcomes (1)

• Manifest refraction

  A qualified ophthalmologist, optometrist, or a trained ophthalmic technician should obtain the refraction, in 0.25D steps, in a calibrated refraction lane. If the subject has a current pair of glasses for distance vision, they can be measured with a lensometer, and these measurements are used as the beginning approximate refraction

  Pre operatively and immediately post operatively

Interventions

Data collection OTHER

Collection of clinical data from groups of patients already implanted with the light adjustable lens (LAL) and have completed light treatments.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 50 commercial patients who have been implanted with the LAL and who have completed Light Delivery Device (LDD) light treatments.

You may qualify if:

• Sign a written Informed Consent Document
• Implanted commercially with the LAL and completed LDD light treatments

You may not qualify if:

• Previous corneal or intraocular surgery other than removal of cataract and implantation of the LAL

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract; Pseudophakia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 5, 2024
• Study Start: August 13, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)