Clinical trial NCT02014389: Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer
Official title: Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Dystrophies
Retinitis Pigmentosa
Glaucoma
Keywords: Retinal Dystrophies
Retinitis Pigmentosa
Glaucoma
Visual Field
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two Groups: 1. Control, 2. Patients - Glaucoma patients with early damage (nasal step) of Humphrey visual field (HVF), Glaucoma patients with advanced damage of HVF (arcuate , tubular vision) and retinal dystrophy patientsl

Brief summary: Objective perimetry can better monitor visual field defects in retinal dystrophy and Glaucoma patients than conventional subjective perimetry. The PLR ( Pupil Light Reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and Glaucoma patients.

Detailed description: Pupil light reflex (PLR) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field.

A computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 LEDs, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old.
* Signing informed consent.
* Pupillary reflex to light.

Exclusion Criteria:

1. Cloudy corneas.
2. Surgical intraocular ophthalmic procedure within the past 30 days.
3. No reactive pupils.
4. Synechia of the iris to the lens after surgery or inflammation.
5. Neovascularization.
6. Axenfeld-Rieger Syndrome.
7. Iris atrophy (ICE syndrome).
8. Iris coloboma.
9. Sphincter damage due to ischemia.
10. Sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle).
11. Sphincter damage due to Herpes Zoster Uveitis.
12. Sphincter damage due to high intraocular pressure.
13. Iris tumor or cyst.
14. Ectropion uvae.
15. Adie's pupil.
16. Third nerve aberrant regeneration of the iris sphincter.
17. RP patients with Optic neuropathy with the potential of producing a positive RAPD (Relative Afferent Pupillary Defect).
18. Chronic use of myotics or mydriatics.
19. Systemic medication that have affect on pupillary reflex .
20. Any condition preventing accurate measurement or examination of the pupil.

Primary outcomes:
measure: PLR response amplitude and latency
timeFrame: single visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
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.