Posterior Capsule Opacification Obscuring VisionNCT04027595
Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists
An observational study of Posterior Capsule Opacification Obscuring Vision, run by Northeastern State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Capsule Opacification Obscuring Vision
- What is being tested?
- Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Existing patients at primary eye care optometric facilities.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern State University
Tahlequah, Oklahoma, 74464
About this study
Official title: 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.
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.
- Being tested
- Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser CapsulotomyProcedure or surgery
A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Visual Acuity
Pre and Post Procedure Visual Acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start17 Sep 2019
- Primary completion22 May 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule Opacification Obscuring VisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Lighthizer, OD, Study director, Northeastern State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027595
- Sponsor's protocol ID
- NSUOCO2020
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists
- ClinicalTrials.gov ID
- NCT04027595
- Acronym / sponsor ID
- NSUOCO2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northeastern State UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing patients at primary eye care optometric facilities.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser CapsulotomyA Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity. | Procedure or surgery | – |
Primary outcome
Central Visual Acuity
Time frame: 3 months
Pre and Post Procedure Visual Acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Lighthizer, OD study director
Northeastern State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Capsule Opacification Obscuring Vision, run by Northeastern State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Visual Acuity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.