NCT01021982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

November 29, 2009

Last Update Submit

November 18, 2014

Conditions

Retinitis PigmentosaGlaucomaVisual Field

Keywords

PupillometerRetinitis PigmentosaGlaucomaObjective perimetry

Outcome Measures

Primary Outcomes (1)

  • PLR response amplitude and latency

    Not defined yet

Study Arms (2)

Glaucoma

Glaucoma Patients with visual field defects

Retinitis Pigmentosa

Retinitis Pigmentosa Patients with visual field defects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Age 18-75
  • Sign on informed consent
  • Papillary response to light.
  • 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 ) .
  • Refractive correction up to -3.5 D.

You may not qualify if:

  • Cloudy corneas.
  • Surgical intraocular ophthalmic procedure within the past 30 days.
  • Nonreactive pupils.
  • Synechia of the iris to the lens after surgery or inflammation .
  • Neovascularization.
  • Iris coloboma.
  • Sphincter damage due to ischemia or trauma (tears of sphincter or diffuse damage to muscle).
  • Sphincter damage due to high intraocular pressure .
  • Iris tumor or cyst .
  • Ectropion uvea .
  • Adie's pupil .
  • Optic neuropathy with the potential for producing a positive RAPD (Relative Afferent Pupillary Defect ).
  • Chronic use of myotics or mydriatics.
  • Systemic Medication which affect on papillary response .
  • Any condition preventing accurate measurement or examination of the pupils.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel, 52621, Israel

Location

Related Publications (5)

  • 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.

    PMID: 10380129BACKGROUND

  • 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.

    PMID: 17573859BACKGROUND

  • Kardon RH. Pupil perimetry. Curr Opin Ophthalmol. 1992 Oct;3(5):565-70. doi: 10.1097/00055735-199210000-00002.

    PMID: 10147922BACKGROUND

  • 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.

    PMID: 2052302BACKGROUND

  • 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.

    PMID: 23482470DERIVED

MeSH Terms

Conditions

Retinitis PigmentosaGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOcular Hypertension

Study Officials

  • Ygal Rotenstreich, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Electrophysiology Clinic, Goldschleger Eye Institute

Study Record Dates

First Submitted

November 29, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

IL(1)