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

Posterior Capsule Opacification Obscuring Vision Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04027595
• Other study ID #: NSUOCO2020
• Status: Active, not recruiting
• Start date: September 17, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2022
• Source: Northeastern State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 30, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification Obscuring Vision

Intervention

Procedure:
• Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy
A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.

Locations

Country	Name	City	State
United States	Northeastern State University	Tahlequah	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Visual Acuity	Pre and Post Procedure Visual Acuity	3 months