- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629129
Effect of Latanoprost on Optic Nerve Perfusion
Optic Nerve Head Perfusion Following Treatment with Latanoprost 0.005% in Primary Open Angle Glaucoma: an Optical Coherence Tomography Angiography Study
Study Overview
Detailed Description
All patients had bilateral primary open angle glaucoma diagnosed by increased IOP, visual field changes, and defective nerve fiber layer thickness (NFLT) on OCT examination.
All patients treated with topical Latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) Inclusion criteria: age > 20 years, newly diagnosed patients with POAG. The exclusion criteria included optic nerve lesions other than glaucomatous changes, All patients completed their ophthalmic examination to detect BCVA, cycloplegic refraction, and anterior segment examination , IOP measuring by applanation tonometer, and indirect ophthalmoscope fundus examination.
Visual field testing. The thickness of NFL around the disc was evaluated using spectral domain optical coherence tomography (OCT) Optovue octa was used to quantify the density of the radial peripapillary capillary (RPC) vessels. This study employed software to quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants.
The mean arterial blood pressure (MAP) was determined by adding the diastolic blood pressure (DBP) to one third of the difference between systolic blood pressure and the diastolic blood pressure.
All eyes were treated with topical latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) with dose of one drop at bedtime. IOP, MOPP, NFLT, and RPC vascular density were measured before the beginning of treatment and 1 and 3 months after treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 44511
- Zagazig University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
POAG with no past ocular surgery or laser retinal treatment. No previous anti-glaucoma medications
Exclusion Criteria:
- optic nerve lesions other than glaucoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: EFFECT OF ANTI GLAUCOMA LATANOPROST 0.005 ON OPTIC NERVE PERFUSION
EFFECT OF ANTI GLAUCOMA PROSTAGLANDIN 0.005 ON OPTIC NERVE PERFUSION
|
MEAN OCULAR PERFUSION PRESSURE WAS MEASURED AND CORRELATED TO THE IOP AND OPTIC NERVE PERFUSION IN RESPONSE TO LATANOPROST TREATMENT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quantify the peri papillary capillary (microvasculature) density using OCTA
Time Frame: 3 months
|
quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Harris A, Migliardi R, Rechtman E, Cole CN, Yee AB, Garzozi HJ. Comparative analysis of the effects of dorzolamide and latanoprost on ocular hemodynamics in normal tension glaucoma patients. Eur J Ophthalmol. 2003 Jan-Feb;13(1):24-31. doi: 10.1177/112067210301300104.
- Gherghel D, Hosking SL, Cunliffe IA, Armstrong RA. First-line therapy with latanoprost 0.005% results in improved ocular circulation in newly diagnosed primary open-angle glaucoma patients: a prospective, 6-month, open-label study. Eye (Lond). 2008 Mar;22(3):363-9. doi: 10.1038/sj.eye.6702639. Epub 2006 Nov 17.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #454/25-June-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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