GlaucomaPhase 4SALTNCT00981435
Steroids After Laser Trabeculoplasty for Glaucoma
A Phase 4 study testing Prednisolone 1%, Ketorolac and Artificial Tears in people with Glaucoma, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Prednisolone 1%, Ketorolac and Artificial Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- clinical diagnosis of glaucoma
- clinician has determined that SLT laser is indicated
- IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)
Who cannot join
- prior history of uveitis
- prior glaucoma surgery including glaucoma laser surgery
- pregnant or 3 months post-partum
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bascom Palmer Eye Institute
Miami, Florida, 33136
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).
Read the detailed description
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.
- Conditions
- Glaucoma
- Being tested
- Prednisolone 1%, Ketorolac, Artificial Tears
- Keywords
- Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone 1%Drug
Also called Pred forte
Prednisolone 1% to lasered eye 4 times/day for 4.5 days
KetorolacDrug
Also called Voltaren
Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days
Artificial TearsDrug
Also called saline tears
Artificial saline tears to lasered eye 4 times/day for 4.5 days
| Study group | Role | What they receive |
|---|---|---|
| Artificial Tears | Experimental | Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. Receives: Drug: Artificial Tears |
| Non-steroidal anti-inflammatory | Experimental | Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. Receives: Drug: Ketorolac |
| Steroid | Experimental | Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. Receives: Drug: Prednisolone 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP) Change
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
Measured: Baseline to Week 12
Secondary outcomes (1)
Intraocular Inflammation
The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Bascom Palmer Eye Institute, University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981435
- Sponsor's protocol ID
- 20081142
- Acronym
- SALT
- Status last verified
- Jul 2019
- First submitted
- 21 Sep 2009
- Last updated
- 7 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD is anticipated to be shared upon publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT
- ClinicalTrials.gov ID
- NCT00981435
- Acronym / sponsor ID
- SALT / 20081142
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Bascom Palmer Eye Institute, University of Pittsburgh Medical Center
- Study start
- Sep 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 14 Apr 2017
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 determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).
Detailed description
SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artificial Tears | Experimental | Drug: Artificial TearsTopical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
| Non-steroidal anti-inflammatory | Experimental | Drug: KetorolacTopical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
| Steroid | Experimental | Drug: Prednisolone 1%Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of glaucoma
- clinician has determined that SLT laser is indicated
- IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)
Key exclusion criteria (3 listed)
- prior history of uveitis
- prior glaucoma surgery including glaucoma laser surgery
- pregnant or 3 months post-partum
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 |
|---|---|---|
| Prednisolone 1%Also: Pred fortePrednisolone 1% to lasered eye 4 times/day for 4.5 days | Drug | Steroid |
| KetorolacAlso: VoltarenKetorolac 0.5% to lasered eye 4 times/day for 4.5 days | Drug | Non-steroidal anti-inflammatory |
| Artificial TearsAlso: saline tearsArtificial saline tears to lasered eye 4 times/day for 4.5 days | Drug | Artificial Tears |
Primary outcome
Intraocular Pressure (IOP) Change
Time frame: Baseline to Week 12
IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.
1 secondary outcome
Intraocular Inflammation
Time frame: Up to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD is anticipated to be shared upon publication of results.
Related trials for Glaucoma
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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.
Jeffrey L Goldberg, MD, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone 1%, Ketorolac and Artificial Tears in people with Glaucoma, run by Stanford University at 2 sites 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 3 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: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (IOP) Change (time frame: Baseline to Week 12). 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 7 Aug 2019.