Evaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer

Glaucoma Clinical Trial

Official title:

Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinal Dystrophy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02014389
• Other study ID #: SHEBA -13 -0640-YR-CTIL
• Status: Recruiting
• Start date: December 1, 2013
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Sheba Medical Center
• Contact: Ygal Rotenstreich, MD
• Phone: 972547898137
• Email: Ygal.Rotenstreich[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Retinal Dystrophies
• Retinitis
• Retinitis Pigmentosa

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLR response amplitude and latency		single visit