Evaluation of Objective Perimetry Using Pupillometer

November 18, 2014 updated by: Dr. Ygal Rotenstreich, Sheba Medical Center

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Glaucoma
Glaucoma Patients with visual field defects
Retinitis Pigmentosa
Retinitis Pigmentosa Patients with visual field defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PLR response amplitude and latency
Time Frame: Not defined yet
Not defined yet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Tel Aviv University, Claire and Amedee Maratier Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 29, 2009

First Submitted That Met QC Criteria

November 29, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-6958-AS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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