Posterior Cornea in Primary Open Angle Glaucoma

• Conditions: Glaucoma
• Interventions: Procedure: Pentacam

• Registration Number: NCT02356094
• Lead Sponsor: Centro Hospitalar do Baixo Vouga

Brief Summary

Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.

Detailed Description

A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-01
• Study First Submitted QC: 2015-02-01
• Last Update Submitted: 2015-02-01
• Study First Posted: 2015-02-05
• Last Update Posted: 2015-02-05
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
• Healthy subjects from the General Ophthalmology Outpatient Clinic

Exclusion Criteria

• age inferior to 18 years old
• primary closed angle glaucoma
• secondary open angle glaucoma
• previous intra-ocular surgery
• known or suspected corneal disease
• previous intra-ocular inflammation
• previous ocular trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Pentacam	Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination
Controls	Pentacam	Control group of age and central corneal thickness matched healthy subjects, randomly selected from the General Ophthalmology Outpatient Clinic to be submitted to Pentacam examination

Primary Outcome Measures

Name	Time	Method
Mean posterior corneal elevation	Single point in time, at baseline at the moment of study enrollment	Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere

Secondary Outcome Measures

Name	Time	Method
Mean anterior corneal elevation	Single point in time, at baseline at the moment of study enrollment	Mean anterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere

Trial Locations

Locations (1)

Centro Hospitalar Baixo Vouga; 🇵🇹 Aveiro, Portugal