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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Posterior Capsule Opacification Obscuring Vision
• Intervention / Treatment: Procedure: Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tahlequah, Oklahoma, United States, 74464
      • Northeastern State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Existing patients at primary eye care optometric facilities.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Visual Acuity	Pre and Post Procedure Visual Acuity	3 months

Collaborators and Investigators

• Sponsor: Northeastern State University
• Investigators: Study Director: Nathan Lighthizer, OD, Northeastern State University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): May 22, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: NSUOCO2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No