Primary Open-Angle Glaucoma, Unspecified EyeSLTNCT04036214
Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)
An observational study of Primary Open-Angle Glaucoma, Unspecified Eye and Ocular Hypertension, run by Northeastern State University at 1 site in United States.
Trial summary
To measure the efficacy and safety outcomes of SLT performed by optometrists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension
- What is being tested?
- Selective Laser Trabeculoplasty
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 30 Aug 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, of Native American or Alaskan Native descent;
- Diagnosed with primary open angle glaucoma or ocular hypertension;
- Documented intraocular pressure greater than or equal to 23 mmHg;
- No prior glaucoma treatment unless treated with one topical drop.
Who cannot join
- History of trauma or ocular surgery within the last 6 months;
- History of corneal dystrophy;
- Current use of topical or systemic steroids;
- Advanced or severe glaucomatous findings based on comprehensive examination;
- Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern State University
Tahlequah, Oklahoma, 74464
About this study
Official title: Selective Laser Trabeculoplasty (SLT): Efficacy and Safety Outcomes of Optometrist (OD) Performed SLT
To measure the efficacy and safety outcomes of SLT performed by optometrists.
Read the detailed description
Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.
- Being tested
- Selective Laser Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Laser TrabeculoplastyDevice
Selective Laser Trabeculoplasty Laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure via Goldmann tonometry
Pre and Post Procedure Intraocular Pressure will be measured using a Goldmann tonometer and will be measured in millimeters of Mercury (mmHg). Percent change in intraocular pressure will be determined.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start21 Aug 2019
- Primary completion8 May 2022
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-Angle Glaucoma, Unspecified EyeStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nate Lighthizer, OD, Principal investigator, Northeastern State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036214
- Sponsor's protocol ID
- NSUOCO0001
- Acronym
- SLT
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Selective Laser Trabeculoplasty (SLT): Efficacy and Safety Outcomes of Optometrist (OD) Performed SLT
- ClinicalTrials.gov ID
- NCT04036214
- Acronym / sponsor ID
- SLT / NSUOCO0001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northeastern State UniversityUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 29 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.
To measure the efficacy and safety outcomes of SLT performed by optometrists.
Detailed description
Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.
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, of Native American or Alaskan Native descent;
- Diagnosed with primary open angle glaucoma or ocular hypertension;
- Documented intraocular pressure greater than or equal to 23 mmHg;
- No prior glaucoma treatment unless treated with one topical drop.
Key exclusion criteria (5 listed)
- History of trauma or ocular surgery within the last 6 months;
- History of corneal dystrophy;
- Current use of topical or systemic steroids;
- Advanced or severe glaucomatous findings based on comprehensive examination;
- Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.
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 |
|---|---|---|
| Selective Laser TrabeculoplastySelective Laser Trabeculoplasty Laser | Device | – |
Primary outcome
Intraocular Pressure via Goldmann tonometry
Time frame: 6 weeks
Pre and Post Procedure Intraocular Pressure will be measured using a Goldmann tonometer and will be measured in millimeters of Mercury (mmHg). Percent change in intraocular pressure will be determined.
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: No
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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.
Nate Lighthizer, OD principal investigator
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 Primary Open-Angle Glaucoma, Unspecified Eye and Ocular Hypertension, 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 5 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?
Intraocular Pressure via Goldmann tonometry (time frame: 6 weeks). 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.