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

Correlation in Retinal Nerve Fiber Layer Thickness in Uveitis and Healthy Eyes Using Scanning Laser Polarimetry and Optical Coherence Tomography

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.

Study Overview

• Status: Completed
• Conditions: Uveitis
• Intervention / Treatment: Device: SD-OCT and SLP using GDx variable corneal compensation

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Croix-Rousse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sixty-eight consecutive patients were screened between May 2015 and October 2015, 3 (4.4%) of whom were excluded based on poor OCT quality criteria, 7 (10.3%) for poor GDx VCC quality criteria, and 4 (5.9%) for poor visual field quality or reliability criteria. Fifty-four patients were included and divided into two groups: 50 healthy eyes in 29 patients and 42 uveitic eyes in 25 patients. Of these 42-uveitic eyes, 25 eyes (59.5%) had active uveitis and 17 eyes (40.5%) had inactive uveitis

Description

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy eyes	Device: SD-OCT and SLP using GDx variable corneal compensation; RNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation
uveitis eyes	Device: SD-OCT and SLP using GDx variable corneal compensation; RNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber thickness (RNFL)	measures are made with spectral domain optical coherence tomography (SD-OCT) in micrometer	at inclusion
Retinal nerve fiber thickness (RNFL)	measures are made with scanning laser polarimetry (SLP) in micrometer	at inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Philippe Denis, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): October 31, 2015
• Study Completion (ACTUAL): October 31, 2015

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: uveitis; SD-OCT; retinal nerve fiber layer thickness; GDx VCC
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: 69HCL17_0303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No