PSLT Compared to Prostaglandin Analogue Eye Drops

Ocular Hypertension Clinical Trial

Official title:

Computer-guided Selective Laser Trabeculoplasty (PSLT) in the Treatment of Ocular Hypertension and Open-angle Glaucoma Compared to Prostaglandin Analogue Eye Drops: a Non-inferiority Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241938
• Other study ID #: 44489320.7.0000.5327
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2022
• Source: Federal University of Rio Grande do Sul
• Contact: Helena Pakter, MD, PhD
• Phone: +55-51-991226968
• Email: Hmpakter[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the efficacy of PSLT and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (OCT) related to pressure change resulting from treatments

Description:

Patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study.

These patients will have both eyes included in the study. A randomization will be made to allocate one eye to receive treatment with PSLT (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control).

Patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and OCT will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ocular hypertension (IOP = 24 mmHg in both eyes) or diagnosis of open-angle glaucoma (POAG) in both eyes

• Proper visualization of angle structures and 360 degree open angles in both eyes

• No previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation

• No use of systemic medications known to increase IOP

Exclusion Criteria:

• Patients using more than two glaucoma medications

• Evidence of any other eye disease that could affect IOP measurement

• Diagnosis of other types of glaucoma

• Patient with mean deviation (MD) less than -12 decibels (dB) on visual perimetry (severe disease)

• Patients with unilateral glaucoma

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Procedure:
• PSLT
PSLT will be performed under topical anesthesia (proxymetacaine hydrochloride 5mg/ml eye drops) using a mirrored gonioscopy lens (Latina Ocular Instruments). A a2 agonist hypotensive eye drops (0.2% brimonidine tartrate) and 2% pilocarpine eye drops are applied 40 minutes before the procedure. After laser treatment, the patient will be instructed to use non-steroidal anti-inflammatory eye drops (thrice daily for 7 days).

Drug:
• Prostaglandin analogue eye drops
Prostaglandin analogue eye drops will be prescribed to be used continuously once a day in the fellow eye.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure change	Intra-ocular pressure change will be similar in both groups	1 week, 2 months, 9 months, 12 months
Secondary	Structural damage	Changes in nerve fiber layer and ganglion cell layer thickness as measured by OCT will be assessed	1 week, 9 months, 12 months
Secondary	Functional damage	Changes in visual function as measured by computerized perimetry will be assessed	1 week, 9 months, 12 months