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Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT02105311
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University

Brief 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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Device: Selective laser trabeculoplasty Drug: Travoprost Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing the Effects of Selective Laser Trabeculoplasty and Travoprost on the Circadian Intraocular Pressure Variation
Study Start Date : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: Selective laser trabeculoplasty
Treating with the selective laser trabeculoplasty
Device: Selective laser trabeculoplasty
Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)
Other Name: The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)

Active Comparator: Travoprost
Using eye drop: travoprost
Drug: Travoprost
Travoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA)
Other Name: Travatan benzalkonium-free




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Position related intraocular pressure [ Time Frame: Six weeks after the treatments ]
    Intraocular pressure different when measuring in the sitting and supine position (include pre- and post-treatment intraocular pressure values

  2. Ocular surface disease [ Time Frame: Six weeks after the treatments ]
    Using the glaucoma symptom scale-10 (GSS-10) and ocular surface disease questionnaire for evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105311


Locations
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Thailand
Songklanagarind Hospital
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Weerawat Kiddee, MD Prince of Songkla University

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Responsible Party: Weerawat Kiddee, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02105311     History of Changes
Other Study ID Numbers: EC57-020-02-1
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weerawat Kiddee, Prince of Songkla University:
Intraocular pressure
Selective laser trabeculoplasty
Travoprost
Ocular surface disease
Glaucoma symptom scale
Additional relevant MeSH terms:
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Benzalkonium Compounds
Travoprost
Antihypertensive Agents
Anti-Infective Agents, Local
Anti-Infective Agents