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OpenTrials
Completed

NCT Number: NCT03206268

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Croix-Rousse University Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SD-OCT and SLP using GDx variable corneal compensation

Device

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

Primary outcomes

  1. Retinal nerve fiber thickness (RNFL)

    Time frame: at inclusion

    measures are made with spectral domain optical coherence tomography (SD-OCT) in micrometer

  2. Retinal nerve fiber thickness (RNFL)

    Time frame: at inclusion

    measures are made with scanning laser polarimetry (SLP) in micrometer

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Real

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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