RNFL Thickness Measurements Obtained Using SD-OCT and SLP Using GDx Variable Corneal Compensation

Completed

• Conditions: Uveitis
• Interventions: Device: SD-OCT and SLP using GDx variable corneal compensation

• Registration Number: NCT03206268
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL) thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.

A descriptive, observational, prospective, consecutive, cross-sectional, controlled, mono-center case series was conducted from May to October 2015. Clinical characteristics, best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An evaluation of anterior chamber inflammation with laser flare cell meter was also carried out. Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2015-10-31
• Study Completion: 2015-10-31
• Status Verified: 2017-04
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• age ≥18 years,
• best-corrected visual acuity better than or equal to 20/40,
• spherical refraction between -6.00 and +3.00 diopters,
• no retinal disease or non-glaucomatous neuropathy, and no ophthalmic surgery in the past 6 months.

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Exclusion Criteria

• Healthy eye were excluded in case of consecutive and reliable abnormal standard automated perimetry with abnormal Glaucoma Hemifield Test and pattern standard deviation outside 95% of normal limits, and optic nerve damage (asymmetric cup-to-disc ratio ≥ 0.2, rim thinning, notching, excavation, or retinal nerve fiber layer defect).
• any history of ophthalmic disease.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
uveitis eyes	SD-OCT and SLP using GDx variable corneal compensation	-
healthy eyes	SD-OCT and SLP using GDx variable corneal compensation	-

Primary Outcome Measures

Name	Time	Method
Retinal nerve fiber thickness (RNFL)	at inclusion	measures are made with scanning laser polarimetry (SLP) in micrometer

Trial Locations

Locations (1)

Croix-Rousse University Hospital; 🇫🇷 Lyon, France