Overview

Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Prince of Songkla University
Treatments:
Benzalkonium Compounds
Travoprost
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).