Clinical trial NCT01021982: Evaluation of Objective Perimetry Using Pupillometer
Official title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Glaucoma
Visual Field
Keywords: Pupillometer
Retinitis Pigmentosa
Glaucoma
Objective perimetry
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University, Claire and Amedee Maratier Institute
First posted: 2009-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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).

Eligibility 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.

Primary outcomes:
measure: PLR response amplitude and latency
timeFrame: Not defined yet
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ygal Rotenstreich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kalaboukhova 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.
citation: Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. doi: 10.1097/00055735-199210000-00002.
citation: Kardon 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.
citation: Skaat 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.