Evaluation of Objective Perimetry Using Pupillometer

Completed

• Conditions: Glaucoma; Retinitis Pigmentosa; Visual Field

• Registration Number: NCT01021982
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-29
• Study First Submitted QC: 2009-11-29
• Study First Posted: 2009-12-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PLR response amplitude and latency	Not defined yet

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel