MyopiaNCT00638430
The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test
An observational study of Myopia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test. Read more about this study
- Who is it for?
- Ages 27 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: tertiary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.
Read the 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.
- Conditions
- Myopia
- Keywords
- myopia, Humphery Matrix 30-2 test
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | low myopic group | |
| 2 | moderate myopic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean defect
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Changwon Kee, M.D., Study chair, Department of Ophthalmology, Samsung Medical Center,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638430
- Sponsor's protocol ID
- Humphrey30-2
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson AJ, Johnson CA. Frequency-doubling technology perimetry and optical defocus. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):4147-52. doi: 10.1167/iovs.02-1076.
PubMed 12939339
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myopic Optical Defocus on the Humphrey Matrix 30-2 Test
- ClinicalTrials.gov ID
- NCT00638430
- Acronym / sponsor ID
- Humphrey30-2
- Conditions
- Myopia
- Keywords
- myopia, Humphery Matrix 30-2 test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of the myopic optical defocus on the Humphrey Matrix 30-2 test.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –low myopic group |
| 2 | – | –moderate myopic group |
Who may qualify
- Ages
- 27 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- tertiary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean defect
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2008.
- Results publication: PubMed 12939339Anderson AJ, Johnson CA. Frequency-doubling technology perimetry and optical defocus. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):4147-52. doi: 10.1167/iovs.02-1076.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changwon Kee, M.D. study chair
Department of Ophthalmology, Samsung Medical Center,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean defect (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00638430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2008.