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Evaluation of Objective Perimetry Using Pupillometer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Martiee Research Foundation
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01021982
First received: November 29, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition
Retinitis Pigmentosa
Glaucoma
Visual Field

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • PLR response amplitude and latency [ Time Frame: Not defined yet ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma
Glaucoma Patients with visual field defects
Retinitis Pigmentosa
Retinitis Pigmentosa Patients with visual field defects

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  1. Age 18-75
  2. Sign on informed consent
  3. Papillary response to light.
  4. 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 ) .
  5. Refractive correction up to -3.5 D.

Exclusion Criteria:

  1. Cloudy corneas.
  2. Surgical intraocular ophthalmic procedure within the past 30 days.
  3. Nonreactive pupils.
  4. Synechia of the iris to the lens after surgery or inflammation .
  5. Neovascularization.
  6. Iris coloboma.
  7. Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
  8. Sphincter damage due to high intraocular pressure .
  9. Iris tumor or cyst .
  10. Ectropion uvea .
  11. Adie's pupil .
  12. Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
  13. Chronic use of myotics or mydriatics.
  14. Systemic Medication which affect on papillary response .
  15. Any condition preventing accurate measurement or examination of the pupils.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021982

Contacts
Contact: Ygal Rotenstreich, MD 972547898137 Ygal.Rotenstreich@sheba.health.gov.il
Contact: Shlomo Melamed, Prof 97235342874 melamed.shlomo@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Ygal Rotenstreich, MD     972547898137     Ygal.Rotenstreich@sheba.health.gov.il    
Contact: Shlomo Melamed, Prof     97235302874     melamed.shlomo@gmail.com    
Principal Investigator: Ygal Rotenstreich, MD            
Sub-Investigator: Alon Skaat, MD            
Sub-Investigator: Shlomo Melamed, Prof            
Sponsors and Collaborators
Sheba Medical Center
Martiee Research Foundation
Investigators
Principal Investigator: Ygal Rotenstreich, MD Sheba Medical Center, Tel Hashomer, Israel
  More Information

Publications:

Responsible Party: Sheba Medical Center, Rotenstreich Ygal MD
ClinicalTrials.gov Identifier: NCT01021982     History of Changes
Other Study ID Numbers: SHEBA-09-6958-AS-CTIL
Study First Received: November 29, 2009
Last Updated: November 29, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
Pupillometer
Retinitis Pigmentosa
Glaucoma
Objective perimetry

Additional relevant MeSH terms:
Glaucoma
Retinitis
Retinitis Pigmentosa
Ocular Hypertension
Eye Diseases
 Retinal Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2013