Retinal DystrophiesNCT02014389
Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer
An observational study of Retinal Dystrophies and Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2013to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl
Who may be able to join
- Age 18-80 years old.
- Signing informed consent.
- Pupillary reflex to light.
Who cannot join
- Cloudy corneas.
- Surgical intraocular ophthalmic procedure within the past 30 days.
- No reactive pupils.
- Synechia of the iris to the lens after surgery or inflammation.
- Neovascularization.
- Axenfeld-Rieger Syndrome.
Show all 20Show fewer
- Iris atrophy (ICE syndrome).
- Iris coloboma.
- Sphincter damage due to ischemia.
- Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
- Sphincter damage due to Herpes Zoster Uveitis.
- Sphincter damage due to high intraocular pressure.
- Iris tumor or cyst.
- Ectropion uvae.
- Adie's pupil.
- Third nerve aberrant regeneration of the iris sphincter.
- RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
- Chronic use of myotics or mydriatics.
- Systemic medication that have affect on pupillary reflex .
- Any condition preventing accurate measurement or examination of the pupil.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52621
Ygal Rotenstreich, MD, 97235302880, Ygal.Rotenstreich@sheba.health.gov.il
About this study
Official title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients
Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.
Read the detailed description
Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.
A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field
- Conditions
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma
- Keywords
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma, Visual Field
- Medical subject headings
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects will be used as control group | |
| Patients | Patients with Glaucoma , Patients with retinal dystrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLR response amplitude and latency
Measured: single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study start1 Dec 2013
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DystrophiesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014389
- Sponsor's protocol ID
- SHEBA -13 -0640-YR-CTIL
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2013
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.
PubMed 23482470
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients
- ClinicalTrials.gov ID
- NCT02014389
- Acronym / sponsor ID
- SHEBA -13 -0640-YR-CTIL
- Conditions
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma
- Keywords
- Retinal Dystrophies, Retinitis Pigmentosa, Glaucoma, Visual Field
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Dec 2013 (estimated)
- 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.
Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.
Detailed description
Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.
A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Healthy subjects will be used as control group |
| Patients | – | –Patients with Glaucoma , Patients with retinal dystrophy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl
Key inclusion criteria (3 listed)
- Age 18-80 years old.
- Signing informed consent.
- Pupillary reflex to light.
Key exclusion criteria (20 listed)
- Cloudy corneas.
- Surgical intraocular ophthalmic procedure within the past 30 days.
- No reactive pupils.
- Synechia of the iris to the lens after surgery or inflammation.
- Neovascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PLR response amplitude and latency
Time frame: single visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 23482470Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.
Related trials for Retinal Dystrophies
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases
RecruitingPhase 1
A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
Stargardt Disease, Stargardt Macular Dystrophy
RecruitingPhase 2/3
Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
Retinitis Pigmentosa (RP), Inherited Retinal Diseases
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.
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 Retinal Dystrophies and Retinitis Pigmentosa, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 25 Apr 2024. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ygal Rotenstreich, MD (972547898137, Ygal.Rotenstreich@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLR response amplitude and latency (time frame: single visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014389, which also lists 1 linked publication.
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 25 Apr 2024.