RECRUITING

Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.

Official Title

Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment

Quick Facts

Study Start:2025-02-14

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06819046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients 18 years and older * Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following: * 24-2 SITA faster within the last 6 months * OCT RNFL and optic nerve examination within the last 6 months * Diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary RNFL, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the RNFL/GCA on examination or imaging * Progressive thinning on SD-OCT of 7 microns in inferior and superior quadrants or \>4 micron loss in global RNFL thickness * Deviation from this ISNT rule (inferior, superior, nasal and temporal order of RNFL thickness with the inferior RNFL quadrant being the thickness) * Candidate for bilateral SLT * Post-washout, post-SLT IOPs between 28-10 * Gonioscopy findings of Schafer grade III and IV	* Patients MD \<-12, HVF defects in both hemispheres or involving fixation * Medication conditions that prevent SLT * Prior use of rho kinase inhibitor * Previous SLT performed on either eye * Prior MIGS implanted in either eye * Prior or current intolerance of a Rho kinase inhibitor * Uncontrolled IOP on maximum tolerated medical therapy; unable to washout * Narrow angles or other angle abnormalities * History of corneal disease or dystrophy, including endothelial dysfunction * History of corneal edema * Current or history of intra-ocular infection or inflammation * History of retinal diseases that will could affect diagnostic testing * Anticipated use of intra-ocular or topical steroids not associated with the study protocol * Current participation of study drugs or devices or within 6 months prior to screening * Pregnant or planning to be pregnant throughout the study * Any condition in the opinion in the investigator that would potentially confound the results of this study

Inclusion Criteria

Exclusion Criteria

* Patients 18 years and older
* Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following:
* 24-2 SITA faster within the last 6 months
* OCT RNFL and optic nerve examination within the last 6 months
* Diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary RNFL, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the RNFL/GCA on examination or imaging
* Progressive thinning on SD-OCT of 7 microns in inferior and superior quadrants or \>4 micron loss in global RNFL thickness
* Deviation from this ISNT rule (inferior, superior, nasal and temporal order of RNFL thickness with the inferior RNFL quadrant being the thickness)
* Candidate for bilateral SLT
* Post-washout, post-SLT IOPs between 28-10
* Gonioscopy findings of Schafer grade III and IV

* Patients MD \<-12, HVF defects in both hemispheres or involving fixation
* Medication conditions that prevent SLT
* Prior use of rho kinase inhibitor
* Previous SLT performed on either eye
* Prior MIGS implanted in either eye
* Prior or current intolerance of a Rho kinase inhibitor
* Uncontrolled IOP on maximum tolerated medical therapy; unable to washout
* Narrow angles or other angle abnormalities
* History of corneal disease or dystrophy, including endothelial dysfunction
* History of corneal edema
* Current or history of intra-ocular infection or inflammation
* History of retinal diseases that will could affect diagnostic testing
* Anticipated use of intra-ocular or topical steroids not associated with the study protocol
* Current participation of study drugs or devices or within 6 months prior to screening
* Pregnant or planning to be pregnant throughout the study
* Any condition in the opinion in the investigator that would potentially confound the results of this study

Contacts and Locations

Study Contact

Cristian Mendez

CONTACT

303-320-1777

cmendez@coaeyes.com

Principal Investigator

Kingsley Okafor, MD

PRINCIPAL_INVESTIGATOR

Colorado Ophthalmology Associates PC

Study Locations (Sites)

Colorado Ophthalmology Associates PC

Denver, Colorado, 50210

United States

Collaborators and Investigators

Sponsor: Colorado Ophthalmology Associates PC

Kingsley Okafor, MD, PRINCIPAL_INVESTIGATOR, Colorado Ophthalmology Associates PC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-14

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2025-02-14

Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

Glaucoma