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Evaluation of Objective Perimetry Using Pupillometer

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ClinicalTrials.gov Identifier: NCT01021982
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : November 19, 2014
Tel Aviv University, Claire and Amedee Maratier Institute
Information provided by (Responsible Party):
Dr. Ygal Rotenstreich, Sheba Medical Center

Brief 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.

Condition or disease
Retinitis Pigmentosa Glaucoma Visual Field

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 Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .
Study Start Date : November 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013

Glaucoma Patients with visual field defects
Retinitis Pigmentosa
Retinitis Pigmentosa Patients with visual field defects

Primary Outcome Measures :
  1. PLR response amplitude and latency [ Time Frame: Not defined yet ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021982

Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University, Claire and Amedee Maratier Institute
Principal Investigator: Ygal Rotenstreich, MD Sheba Medical Center Tel-Hashomer, Israel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ygal Rotenstreich, Director, Electrophysiology Clinic, Goldschleger Eye Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01021982     History of Changes
Other Study ID Numbers: SHEBA-09-6958-AS-CTIL
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Dr. Ygal Rotenstreich, Sheba Medical Center:
Retinitis Pigmentosa
Objective perimetry

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