Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT

• Sponsor: Yonsei University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00741130
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

Because the measurement of the retinal nerve fiber layer thickness is very sensitive to the position of measurement, it may be incorrect in patients with the tilted disc. In the present study, the corrected RNFL thickness by the optic nerve head configuration using the Cirrus HD OCT will be evaluated. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Myopia

Detailed Description

Finding the localized retinal nerve fiber layer (RNFL) defect and measuring the RNFL thickness are two main issues for early glaucoma detection. A recently developed imaging device, the Cirrus HD OCT, offers more detailed informations about retina architecture including optic nerve head. To calculate the RNFL thickness, the software of the Cirrus HD OCT supposes an ideal optic nerve head. However, in the cases with not ideal optic disc configuration, the measurement of the RNFL thickness is not correct. Because the measurement of the RNFL thickness is extremely sensitive to the position of measurement, patients with the tilted disc are in danger of misdiagnosis. In the present study, we want to correct the RNFL thickness measurement according to the optic nerve head configuration using the Cirrus HD OCT. If the corrected RNFL thickness is more sensitive to detect the localized RNFL defect, the present software should be upgrade to reflect the optic nerve head configuration.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Corrected Measurement of the Retinal Nerve Fiber Layer Thickness by Optic Disc Configuration With the Cirrus HD OCT
• Study Start Date: Jul 1, 2008
• Anticipated Primary Completion Date: Oct 1, 2008
• Anticipated Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
C normal volunteers
G glaucoma patients

Outcome Measures

Primary Outcome Measures

1. the Cirrus HD OCT [when the OCT images are taking]

Secondary Outcome Measures

1. automated visual field [when the OCT images are taking]

2. red-free fundus photo [when the OCT images are taking]

3. refractive errors [when the OCT images are taking]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• normal controls or glaucoma patients

• signal intensity of the OCT image > 8

• cooperative subjects

Exclusion Criteria:

• spherical equivalent refractive errors > +4 diopters or < -4 diopters

• significant media opacity

• previous intraocular surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gong Je Seong	Seoul		Korea, Republic of	135-720

Sponsors and Collaborators

• Yonsei University

Investigators

• Study Chair: Gong Je Seong, MD, PhD, Yonsei University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00741130
• Other Study ID Numbers: 3-2008-0076
• First Posted: Aug 26, 2008
• Last Update Posted: Aug 26, 2008
• Last Verified: Aug 1, 2008

• Keywords provided by , ,: retinal nerve fiber layer; optic nerve head; Cirrus OCT
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Aug 26, 2008