Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT02105311

Collaborator

(none)

Enrollment

Location

Arms

23.1

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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 Names: 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 Names: Travatan benzalkonium-free

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 Names:

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 Names:

Travatan benzalkonium-free

Outcome Measures

Primary Outcome Measures

Change of circadian intraocular pressure [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

Position related intraocular pressure [Six weeks after the treatments]
Intraocular pressure different when measuring in the sitting and supine position (include pre- and post-treatment intraocular pressure values
Ocular surface disease [Six weeks after the treatments]
Using the glaucoma symptom scale-10 (GSS-10) and ocular surface disease questionnaire for evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).