Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure

Prince of Songkla University

Status and phase

Completed

Phase 4

Conditions

Intraocular Pressure

Treatments

Drug: Travoprost

Device: Selective laser trabeculoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT02105311

EC57-020-02-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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).