GlaucomaSLTNCT00986141
Effects of Selective Laser Trabeculoplasty
An observational study of Glaucoma, run by University of Kentucky at 1 site in United States.
Trial summary
Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Surgery and Selective Laser Trabeculoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2012
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thirty patients, between the ages of 40 and 80, of either gender, from all ethnic backgrounds will be recruited in this study.
Who may be able to join
- Subjects who have the diagnosis of open angle glaucoma
- Subjects who are able to speak and understand English and provide meaningful written informed consent,
- Subjects who are willing and able to comply with all testing and requirements defined in the protocol and willing and able to comply with all required study visits.
Who cannot join
- Subjects with previous laser treatment or intraocular surgery,
- Subjects with history of ocular inflammation and with history of previous ocular trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Selective Laser Trabeculoplasty (SLT) on Diurnal Intraocular Pressure in Open-Angle Glaucoma Patients on Medical Treatment
Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).
Read the detailed description
This is a prospective observational study of OAG patients undergoing selective laser trabeculoplasty at the University of Kentucky Chandler Medical Center. The patients will be recruited over 12 months. Study will include 3 visits: pre-laser visit, visit for laser treatment and post-laser visit. All visits will occur within a 3-month period.
- Conditions
- Glaucoma
- Being tested
- Surgery, Selective Laser Trabeculoplasty
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty for glaucoma
Selective Laser TrabeculoplastyProcedure or surgery
Also called SLT
Glaucoma Treatment
| Study group | Role | What they receive |
|---|---|---|
| laser trabeculoplasty | Subjects with POAG and on medical treatment who are undergoing SLT Receives: Procedure: Surgery; Procedure: Selective Laser Trabeculoplasty | |
| Surgery | Glaucoma laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: PI left the University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Davis, Assoc V Chair, Study director, Univ of KY Reseach Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986141
- Sponsor's protocol ID
- IRB 09-0315
- Acronym
- SLT
- Status last verified
- Apr 2013
- First submitted
- 25 Sep 2009
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selective Laser Trabeculoplasty (SLT) on Diurnal Intraocular Pressure in Open-Angle Glaucoma Patients on Medical Treatment
- ClinicalTrials.gov ID
- NCT00986141
- Acronym / sponsor ID
- SLT / IRB 09-0315
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the University
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Sep 2009 (estimated)
- 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.
Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).
Detailed description
This is a prospective observational study of OAG patients undergoing selective laser trabeculoplasty at the University of Kentucky Chandler Medical Center. The patients will be recruited over 12 months. Study will include 3 visits: pre-laser visit, visit for laser treatment and post-laser visit. All visits will occur within a 3-month period.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser trabeculoplasty | – | Procedure: Surgery, Procedure: Selective Laser TrabeculoplastySubjects with POAG and on medical treatment who are undergoing SLT |
| Surgery | – | –Glaucoma laser treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients, between the ages of 40 and 80, of either gender, from all ethnic backgrounds will be recruited in this study.
Key inclusion criteria (3 listed)
- Subjects who have the diagnosis of open angle glaucoma
- Subjects who are able to speak and understand English and provide meaningful written informed consent,
- Subjects who are willing and able to comply with all testing and requirements defined in the protocol and willing and able to comply with all required study visits.
Key exclusion criteria (2 listed)
- Subjects with previous laser treatment or intraocular surgery,
- Subjects with history of ocular inflammation and with history of previous ocular trauma.
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 |
|---|---|---|
| SurgeryAlso: Selective Laser TrabeculoplastySelective Laser Trabeculoplasty for glaucoma | Procedure or surgery | laser trabeculoplasty |
| Selective Laser TrabeculoplastyAlso: SLTGlaucoma Treatment | Procedure or surgery | laser trabeculoplasty |
Primary outcome
To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients.
Time frame: Three years
Results and safety
The study was stopped early (reason given: PI left the University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
Related trials for Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
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.
Deborah Davis, Assoc V Chair study director
Univ of KY Reseach Foundation
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 Glaucoma, run by University of Kentucky 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 Apr 2013. 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?
The study was stopped early (reason given: PI left the University). 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?
To evaluate the effect of selective laser trabeculoplasty on the diurnal intraocular pressure variation in OAG patients. (time frame: Three years). 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 24 Apr 2013.