The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00638430

Purpose

The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.

Condition
Myopia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

mean defect [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	40
Study Start Date:	March 2007
Study Completion Date:	March 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 low myopic group
2 moderate myopic group

Detailed Description:

The Humphery Matrix (Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA), which is a recently developed version of FDT perimetry, showed more improved technology to detect early glaucomatous damage. The user's guide for the Humphrey Matrix (Humphrey® matrix visual field instrument user's guide. Zeiss, Dublin, California, USA; in cooperation with Welch Allyn, Skaneateles, New York, USA; 2003) suggests that myopic refractive errors more than -3.0 D need to be corrected before the 30-2 test. However, the proper correction of the optical defocus is not always easy because of a lack of trial frame.

The purpose of the present study is twofold. At first, the influence of the low-grade myopia on the Humphery Matrix 30-2 test will be evaluated and compared to the effect of moderate-grade myopia. Secondly, the influence of myopic optical defocus and the glaucomatous visual field damage on the pattern deviation plot change according to the severity of glaucomatous visual field damage will be estimated.

Eligibility

Ages Eligible for Study:	27 Years to 61 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

tertiary care clinic

Criteria

Inclusion Criteria:

intra-ocular pressure 23 or higher
suspicious glaucomatous optic disc change
suspicious defect of retinal nerve fiber layer
or eyes with various degrees of glaucoma

Exclusion Criteria:

a high myopic eye (SE more than -6.0 D)
moderate to severe cataract
evidence of diabetic or hypertensive retinopathy
macular disease
intra-ocular inflammation
history of intraocular surgery and any other ocular lesion that could have an influence on the perimetry result

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638430

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 130-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Study Chair:

Changwon Kee, M.D.

Department of Ophthalmology, Samsung Medical Center,

More Information

Publications of Results:

Anderson AJ, Johnson CA. Frequency-doubling technology perimetry and optical defocus. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):4147-52.

Responsible Party:	Department of Ophthalmology, Samsung Medical Center, ( Changwon Kee )
Study ID Numbers:	Humphrey30-2
Study First Received:	March 12, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00638430
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

myopia
Humphery Matrix 30-2 test

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 16, 2009