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

NCT ID: NCT03206268

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Uveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy eyes

SD-OCT and SLP using GDx variable corneal compensation

Intervention Type DEVICE

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

uveitis eyes

SD-OCT and SLP using GDx variable corneal compensation

Intervention Type DEVICE

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

Interventions

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SD-OCT and SLP using GDx variable corneal compensation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Denis

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Croix-Rousse University Hospital

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0303

Identifier Type: -

Identifier Source: org_study_id

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