Evaluation of Objective Perimetry Using Pupillometer

Glaucoma Clinical Trial

Official title:

Objective Perimetry in Normal Subjects,Glaucoma Patients and Retinitis Pigmentosa Patients .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021982
• Other study ID #: SHEBA-09-6958-AS-CTIL
• Status: Completed
• Phase: N/A
• First received: November 29, 2009
• Last updated: November 18, 2014
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Retinitis
• Retinitis Pigmentosa
• Visual Field

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel Aviv University, Claire and Amedee Maratier Institute

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Kalaboukhova L, Fridhammar V, Lindblom B. Relative afferent pupillary defect in glaucoma: a pupillometric study. Acta Ophthalmol Scand. 2007 Aug;85(5):519-25. Epub 2007 Jun 15. — View 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. — View Citation

Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLR response amplitude and latency		Not defined yet	No