ClinicalTrials.gg
Status unknownNCT04027595Updated Sep 1, 2022

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

An observational study in Posterior Capsule Opacification Obscuring Vision, sponsored by Northeastern State University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.

Sponsored by Northeastern State University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Posterior Capsule Opacification Obscuring Vision

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03

In context

Capsule Opacification

28 studies on the registry are indexed under Capsule Opacification; 2 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 11 observational studies indexed under Capsule Opacification.

Browse Capsule Opacification studies →

Lead sponsor

Northeastern State University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Existing patients at primary eye care optometric facilities.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to provide written ;
  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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • ProcedureNeodymium-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.

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What researchers measure

Primary outcomes

  1. Central Visual Acuity

    Pre and Post Procedure Visual Acuity

    Time frame: 3 months

07

Study locations

1 site
  • Northeastern State University
    Tahlequah, Oklahoma 74464, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in May 2022, 32 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2019
First posted
Jul 22, 2019
StartActual
Sep 17, 2019
Primary completionActual
May 22, 2022
CompletionEst.
Sep 30, 2022
Last update
Sep 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04027595
Lead sponsor
Northeastern State University
Responsible party
Sponsor
First posted
Jul 22, 2019
Start date
Sep 17, 2019
Primary completion
May 22, 2022
Completion
Sep 30, 2022 (estimated)
Last update
Sep 1, 2022

Study contacts

Nathan Lighthizer, OD
study director · Northeastern State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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