Retinitis PigmentosaNCT01021982
Evaluation of Objective Perimetry Using Pupillometer
An observational study of Retinitis Pigmentosa and Glaucoma, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinitis Pigmentosa, Glaucoma, Visual Field
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Jan 2013
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Age 18-75
- Sign on informed consent
- Papillary response to light.
- Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) .
- Refractive correction up to -3.5 D.
Who cannot join
- Cloudy corneas.
- Surgical intraocular ophthalmic procedure within the past 30 days.
- Nonreactive pupils.
- Synechia of the iris to the lens after surgery or inflammation .
- Neovascularization.
- Iris coloboma.
Show all 15Show fewer
- Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
- Sphincter damage due to high intraocular pressure .
- Iris tumor or cyst .
- Ectropion uvea .
- Adie's pupil .
- Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
- Chronic use of myotics or mydriatics.
- Systemic Medication which affect on papillary response .
- Any condition preventing accurate measurement or examination of the pupils.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .
Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.
Read the detailed description
Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis.
Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).
- Conditions
- Retinitis Pigmentosa, Glaucoma, Visual Field
- Keywords
- Pupillometer, Retinitis Pigmentosa, Glaucoma, Objective perimetry
- Medical subject headings
- 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 |
|---|---|---|
| Glaucoma | Glaucoma Patients with visual field defects | |
| Retinitis Pigmentosa | Retinitis Pigmentosa Patients with visual field defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLR response amplitude and latency
Measured: Not defined yet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University, Claire and Amedee Maratier Institute
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
- Investigators
- Ygal Rotenstreich, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021982
- Sponsor's protocol ID
- SHEBA-09-6958-AS-CTIL
- Status last verified
- Nov 2014
- First submitted
- 29 Nov 2009
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoshitomi T, Matsui T, Tanakadate A, Ishikawa S. Comparison of threshold visual perimetry and objective pupil perimetry in clinical patients. J Neuroophthalmol. 1999 Jun;19(2):89-99.
PubMed 10380129Kalaboukhova L, Fridhammar V, Lindblom B. Relative afferent pupillary defect in glaucoma: a pupillometric study. Acta Ophthalmol Scand. 2007 Aug;85(5):519-25. doi: 10.1111/j.1600-0420.2006.00863.x. Epub 2007 Jun 15.
PubMed 17573859Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. doi: 10.1097/00055735-199210000-00002.
PubMed 10147922Kardon RH, Kirkali PA, Thompson HS. Automated pupil perimetry. Pupil field mapping in patients and normal subjects. Ophthalmology. 1991 Apr;98(4):485-95; discussion 495-6. doi: 10.1016/s0161-6420(91)32267-x.
PubMed 2052302Skaat 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 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .
- ClinicalTrials.gov ID
- NCT01021982
- Acronym / sponsor ID
- SHEBA-09-6958-AS-CTIL
- Conditions
- Retinitis Pigmentosa, Glaucoma, Visual Field
- Keywords
- Pupillometer, Retinitis Pigmentosa, Glaucoma, Objective perimetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University, Claire and Amedee Maratier Institute
- Study start
- Nov 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Dec 2009 (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 RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.
Detailed description
Pupil light reflex will be measured by a pupillometer in response to short and long wavelength light small spot stimulus in different area of the visual field. The PRL will be measured in four quadrant, central, 10, 20, and 30 degree from the visual axis.
Stimulus duration will be 1000 ms (1 sec), with intervals of 890 ms between stimuli. The stimuli size V with light intensity of 39.8 cd-s/m2 for both short wavelength stimuli (peak 485 nm) and long wavelength stimuli (peak 620nm).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | –Glaucoma Patients with visual field defects |
| Retinitis Pigmentosa | – | –Retinitis Pigmentosa Patients with visual field defects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (5 listed)
- Age 18-75
- Sign on informed consent
- Papillary response to light.
- Groups of : Normal , Glaucoma patients with early glaucoma damage on HVF (nasal step ect. ), Glaucoma patients with advanced glaucoma damage on HVF (arcuate , tubular vision ) and RP patients (Early VF damage , ring scotoma ) .
- Refractive correction up to -3.5 D.
Key exclusion criteria (15 listed)
- Cloudy corneas.
- Surgical intraocular ophthalmic procedure within the past 30 days.
- Nonreactive 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: Not defined yet
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 19 Nov 2014.
- Background: PubMed 10380129Yoshitomi T, Matsui T, Tanakadate A, Ishikawa S. Comparison of threshold visual perimetry and objective pupil perimetry in clinical patients. J Neuroophthalmol. 1999 Jun;19(2):89-99.
- Background: PubMed 17573859Kalaboukhova L, Fridhammar V, Lindblom B. Relative afferent pupillary defect in glaucoma: a pupillometric study. Acta Ophthalmol Scand. 2007 Aug;85(5):519-25. doi: 10.1111/j.1600-0420.2006.00863.x. Epub 2007 Jun 15.
- Background: PubMed 10147922Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. doi: 10.1097/00055735-199210000-00002.
- Background: PubMed 2052302Kardon RH, Kirkali PA, Thompson HS. Automated pupil perimetry. Pupil field mapping in patients and normal subjects. Ophthalmology. 1991 Apr;98(4):485-95; discussion 495-6. doi: 10.1016/s0161-6420(91)32267-x.
- Derived from this study: 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.
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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.
Ygal Rotenstreich, MD principal investigator
Sheba Medical Center
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 Retinitis Pigmentosa and Glaucoma, 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 5 inclusion and 15 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 19 Nov 2014. 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?
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?
PLR response amplitude and latency (time frame: Not defined yet). 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 NCT01021982, which also lists 5 linked publications.
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 19 Nov 2014.