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

NCT03206268 | Completed

• 1 other identifier: 69HCL17_0303
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

retinal nerve fiber layer thickness; uveitis; SD-OCT; GDx VCC

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

healthy eyes

Device: SD-OCT and SLP using GDx variable corneal compensation

uveitis eyes

Device: SD-OCT and SLP using GDx variable corneal compensation

Interventions

SD-OCT and SLP using GDx variable corneal compensation DEVICE

RNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation

healthy eyes; uveitis eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix-Rousse University Hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Philippe Denis

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: July 2, 2017
• Study Start: May 1, 2015
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: May 16, 2018

Record last verified: 2017-04

Locations

FR (1)