Clinical trial NCT02628223: 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
Official title: A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Ocular Hypertension
Glaucoma, Open Angle, Pseudo-exfoliative
Pigment Dispersion Syndrome
Glaucoma
Keywords: glaucoma
Elevated IOP
Selective Laser Trabeculoplasty
SLT
open angle glaucoma
ocular hypertension
Glaucoma, Open Angle, Pseudo-exfoliative
pigment dispersion syndrome
Pseudoexfoliation
IOP ≥ 21 mmHg
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Detailed description: This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Eligibility criteria: Inclusion Criteria:

* patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
* greater than 18 years of age
* initial intraocular pressure (IOP) of ≥ 21 mmHg

Exclusion Criteria:

* prior medical or laser therapy to lower IOP
* previous incisional glaucoma surgery before the study period

Primary outcomes:
measure: Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
timeFrame: 1 year
measure: Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required
timeFrame: within 1 year of study intervention
measure: Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
timeFrame: within 1 year of study intervention
Other outcomes:
measure: Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry
timeFrame: within 1 year of study intervention
measure: Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy
timeFrame: within 1 year of study intervention
Locations:
city: Wilmington
country: United States
facility: Brandywine Eye Center
state: Delaware
city: Thorndale
country: United States
facility: Levin Luminais Chronister Eye Associates
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Jeffrey D. Henderer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Sophia Siu, MD
role: STUDY_DIRECTOR
References: