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

• Sponsor: Northeastern State University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04027595
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 12.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posterior Capsule Opacification Obscuring Vision	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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists
• Actual Study Start Date: Sep 17, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Central Visual Acuity [3 months]

   Pre and Post Procedure Visual Acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeastern State University	Tahlequah	Oklahoma	United States	74464

Sponsors and Collaborators

• Northeastern State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northeastern State University
• ClinicalTrials.gov Identifier: NCT04027595
• Other Study ID Numbers: NSUOCO2020
• First Posted: Jul 22, 2019
• Last Update Posted: Feb 27, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Capsule Opacification

Study Results

No Results Posted as of Feb 27, 2020