UveitisRealNCT03206268
RNFL Thickness Measurements Obtained Using SD-OCT and SLP Using GDx Variable Corneal Compensation
An observational study of Uveitis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- What is being tested?
- SD-OCT and SLP using GDx variable corneal compensation
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2015to 31 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Uveitis
- Being tested
- SD-OCT and SLP using GDx variable corneal compensation
- Keywords
- retinal nerve fiber layer thickness, uveitis, SD-OCT, GDx VCC
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-OCT and SLP using GDx variable corneal compensationDevice
RNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation
| Study group | Role | What they receive |
|---|---|---|
| healthy eyes | Not described Receives: Device: SD-OCT and SLP using GDx variable corneal compensation | |
| uveitis eyes | Not described Receives: Device: SD-OCT and SLP using GDx variable corneal compensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber thickness (RNFL)
measures are made with spectral domain optical coherence tomography (SD-OCT) in micrometer
Measured: at inclusion
Retinal nerve fiber thickness (RNFL)
measures are made with scanning laser polarimetry (SLP) in micrometer
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 May 2015
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Denis, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206268
- Sponsor's protocol ID
- 69HCL17_0303
- Acronym
- Real
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation in Retinal Nerve Fiber Layer Thickness in Uveitis and Healthy Eyes Using Scanning Laser Polarimetry and Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03206268
- Acronym / sponsor ID
- Real / 69HCL17_0303
- Conditions
- Uveitis
- Keywords
- retinal nerve fiber layer thickness, uveitis, SD-OCT, GDx VCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy eyes | – | Device: SD-OCT and SLP using GDx variable corneal compensation |
| uveitis eyes | – | Device: SD-OCT and SLP using GDx variable corneal compensation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD-OCT and SLP using GDx variable corneal compensationRNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation | Device | healthy eyes, uveitis eyes |
Primary outcome
Retinal nerve fiber thickness (RNFL)
Time frame: at inclusion
measures are made with spectral domain optical coherence tomography (SD-OCT) in micrometer
Retinal nerve fiber thickness (RNFL)
Time frame: at inclusion
measures are made with scanning laser polarimetry (SLP) in micrometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Denis principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber thickness (RNFL) (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.