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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00638430
Other study ID # Humphrey30-2
Secondary ID
Status Completed
Phase N/A
First received March 12, 2008
Last updated March 12, 2008
Start date March 2007
Est. completion date March 2008

Study information

Verified date March 2008
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2008
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 27 Years to 61 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary mean defect 15 minutes No
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