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

Uveitis Clinical Trial

— Real  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206268
• Other study ID #: 69HCL17_0303
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: October 31, 2015

Study information

• Verified date: April 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 31, 2015
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis

Intervention

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

Locations

Country	Name	City	State
France	Croix-Rousse University Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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