NCT04027595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

2.7 years

First QC Date

July 18, 2019

Last Update Submit

August 30, 2022

Conditions

Posterior Capsule Opacification Obscuring Vision

Outcome Measures

Primary Outcomes (1)

  • Central Visual Acuity

    Pre and Post Procedure Visual Acuity

    3 months

Interventions

Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser CapsulotomyPROCEDURE

A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Existing patients at primary eye care optometric facilities.

You may qualify if:

  • Ability to provide written informed consent;
  • At least 18 years of age, male or female;
  • Prior cataract surgery;
  • Diagnosed with posterior capsule opacification obstructing vision;
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern State University

Tahlequah, Oklahoma, 74464, United States

Location

Study Officials

  • Nathan Lighthizer, OD

    Northeastern State University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 22, 2019

Study Start

September 17, 2019

Primary Completion

May 22, 2022

Study Completion

September 30, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

US(1)