Intraocular PressurePhase 4NCT02105311
Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure
A Phase 4 study testing Selective laser trabeculoplasty and Travoprost in people with Intraocular Pressure, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Selective laser trabeculoplasty and Travoprost
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2014to Feb 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Age > 18 year-old
- Patients who were diagnosed as primary open-angle glaucoma, normal tension glaucoma, and ocular hypertension either newly diagnosed or currently on medical therapy.
- Agree to participate in the study, accept to be randomized to receive treatment, and willing to sign an informed consent
Who cannot join
- Related to the severity of disease and visual acuity status
- Advance glaucoma in the study eye
- Have a very high intraocular pressure that need immediate treatment to prevent retinal vein occlusion (intraocular pressure >30 mmHg)
- Currently on maximal tolerated medical treatment and unable to control intraocular pressure
- Currently on oral carbonic anhydrase inhibitor for intraocular pressure control
- Single eye, the other eye blind from any cause
Show all 31Show fewer
- Related to surgical procedures
- Prior laser trabeculoplasty
- Prior glaucoma surgery
- Prior retinal surgery
- Underwent less than 3-month cataract extraction
- Potential need for other ocular surgery within the 2-3-month follow-up period since enrollment Related to underlying and ocular history
- History of diabetic retinopathy staged as severe non-proliferative or worse
- Narrow iridocorneal angle
- Ocular condition precluding visualization of trabecular meshwork
- Recently have ocular inflammation of any cause
- Previous history of ocular trauma
- Pregnant or breast-feeding women Related to the difficulty of having reliable measurements
- History of refractive surgery or any keratoplastic procedure
- Corneal opacities or diseases making no suitable tonometry
- Subjects with having poor or eccentric fixation or nystagmus
- Excessive eye squeezing
- Unable to lay down for measuring intraocular pressure in supine position during the night time
- Unable to have intraocular pressure checked every 2-hour such as have complicated underlying diseases or having sleep deprivation Related to allergy
- Known allergy to topical anesthesia
- Known allergy to fluorescein solution
- Known allergy to travoprost Related to compliance
- Impairment preventing adequate understanding to sign an informed consent
- Subject has demonstrated potential for non-compliance with the study protocol
- Unwilling to be randomized to receive treatment
- Unwilling to be washed out from currently treated drug(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Study Comparing the Effects of Selective Laser Trabeculoplasty and Travoprost on the Circadian Intraocular Pressure Variation
The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.
Read the detailed description
Selective laser trabeculoplasty is an effective treatment for lowering intraocular pressure in patients with open-angle glaucoma. Clinical evaluations of its effectiveness in individual patients usually are derived from baseline and post-laser measurements of intraocular pressure during office hours in the sitting position. Only a few studies have examined the efficacy of laser trabeculoplasty beyond office hours. Although the 24-hour effect of laser trabeculoplasty has been studied ,the study was conducted before the use of these new and more potent intraocular pressure lowering drugs. So it doesn't have any study to determine the effect of selective laser trabeculoplasty and travoprost to reduce the diurnal and nocturnal variation of Iintraocular pressure.
- Conditions
- Intraocular Pressure
- Being tested
- Selective laser trabeculoplasty, Travoprost
- Keywords
- Intraocular pressure, Selective laser trabeculoplasty, Travoprost, Ocular surface disease, Glaucoma symptom scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective laser trabeculoplastyDevice
Also called The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)
Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)
TravoprostDrug
Also called Travatan benzalkonium-free
Travoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA)
| Study group | Role | What they receive |
|---|---|---|
| Selective laser trabeculoplasty | Experimental | Treating with the selective laser trabeculoplasty Receives: Device: Selective laser trabeculoplasty |
| Travoprost | Active comparator | Using eye drop: travoprost Receives: Drug: Travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of circadian intraocular pressure
intraocular pressure values measured during daytime and nighttime, compare between selective laser trabeculoplasty and travoprost (include pre- and post-treatment intraocular pressure values)
Measured: Six weeks after recieving treatment
Secondary outcomes (2)
Position related intraocular pressure
Intraocular pressure different when measuring in the sitting and supine position (include pre- and post-treatment intraocular pressure values
Measured: Six weeks after the treatments
Ocular surface disease
Using the glaucoma symptom scale-10 (GSS-10) and ocular surface disease questionnaire for evaluation
Measured: Six weeks after the treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105311
- Sponsor's protocol ID
- EC57-020-02-1
- Status last verified
- Aug 2016
- First submitted
- 28 Mar 2014
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing the Effects of Selective Laser Trabeculoplasty and Travoprost on the Circadian Intraocular Pressure Variation
- ClinicalTrials.gov ID
- NCT02105311
- Acronym / sponsor ID
- EC57-020-02-1
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular pressure, Selective laser trabeculoplasty, Travoprost, Ocular surface disease, Glaucoma symptom scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Apr 2014 (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.
The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.
Detailed description
Selective laser trabeculoplasty is an effective treatment for lowering intraocular pressure in patients with open-angle glaucoma. Clinical evaluations of its effectiveness in individual patients usually are derived from baseline and post-laser measurements of intraocular pressure during office hours in the sitting position. Only a few studies have examined the efficacy of laser trabeculoplasty beyond office hours. Although the 24-hour effect of laser trabeculoplasty has been studied ,the study was conducted before the use of these new and more potent intraocular pressure lowering drugs. So it doesn't have any study to determine the effect of selective laser trabeculoplasty and travoprost to reduce the diurnal and nocturnal variation of Iintraocular pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective laser trabeculoplasty | Experimental | Device: Selective laser trabeculoplastyTreating with the selective laser trabeculoplasty |
| Travoprost | Active comparator | Drug: TravoprostUsing eye drop: travoprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 year-old
- Patients who were diagnosed as primary open-angle glaucoma, normal tension glaucoma, and ocular hypertension either newly diagnosed or currently on medical therapy.
- Agree to participate in the study, accept to be randomized to receive treatment, and willing to sign an informed consent
Key exclusion criteria (31 listed)
- Related to the severity of disease and visual acuity status
- Advance glaucoma in the study eye
- Have a very high intraocular pressure that need immediate treatment to prevent retinal vein occlusion (intraocular pressure >30 mmHg)
- Currently on maximal tolerated medical treatment and unable to control intraocular pressure
- Currently on oral carbonic anhydrase inhibitor for intraocular pressure control
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 trabeculoplastyAlso: The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel) | Device | Selective laser trabeculoplasty |
| TravoprostAlso: Travatan benzalkonium-freeTravoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA) | Drug | Travoprost |
Primary outcome
Change of circadian intraocular pressure
Time frame: Six weeks after recieving treatment
intraocular pressure values measured during daytime and nighttime, compare between selective laser trabeculoplasty and travoprost (include pre- and post-treatment intraocular pressure values)
2 secondary outcomes
Position related intraocular pressure
Time frame: Six weeks after the treatments
Ocular surface disease
Time frame: Six weeks after the treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- 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.
Weerawat Kiddee, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective laser trabeculoplasty and Travoprost in people with Intraocular Pressure, run by Prince of Songkla University at 1 site in Thailand.
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 31 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 8 Aug 2016. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of circadian intraocular pressure (time frame: Six weeks after recieving treatment). 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 8 Aug 2016.