Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists

• Conditions: Posterior Capsule Opacification Obscuring Vision

• Registration Number: NCT04027595
• Lead Sponsor: Northeastern State University

Brief Summary

The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.

Detailed Description

Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Study Start: 2019-09-17
• Primary Completion: 2022-05-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-01
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Ability to provide written informed consent;
2. At least 18 years of age, male or female;
3. Prior cataract surgery;
4. Diagnosed with posterior capsule opacification obstructing vision;
5. Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living

Exclusion Criteria

1. History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings)
2. Previous myopic refractive error greater than 6.00 diopters
3. Complications following previous ocular procedures (i.e. intraocular lens decentration)
4. Ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Visual Acuity	3 months	Pre and Post Procedure Visual Acuity

Trial Locations

Locations (1)

Northeastern State University; 🇺🇸 Tahlequah, Oklahoma, United States