OCT Agreement and Crossed Precision Study

Glaucoma Clinical Trial

Official title:

Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050880
• Other study ID #: RS-3000 series Protocol 1
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: September 25, 2014
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria: NORMAL EYES

• Subjects who do not have pathology in both eyes

Inclusion Criteria: GLAUCOMA

• Subjects who have a glaucoma diagnosis

Inclusion Criteria: RETINAL

• Subjects who have a retinal diagnosis including but not limited to:

1. Diabetic macular edema

2. Dry age related macular degeneration

3. Wet age related macular degeneration

4. Cystoid macular edema

5. Epiretinal membrane

6. Macular hole

Inclusion Criteria: CORNEAL

• Subjects who has one of these diagnosis:

1. Post status LASIK surgery

2. Keratoconus

3. Other corneal dystrophies or degenerations.

Exclusion Criteria: ALL EYES

• Subjects who have any of the following conditions

1. Diabetes mellitus (DM) and/or diabetic retinopathy

2. Uncontrolled Hypertension (HT)

3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision

4. Cardiac, hepatic, renal and hematologic diseases

5. A current condition requiring systemic administration of steroid

6. A history of, or currently receiving, anticancer therapy

7. Epileptic seizures which are optically induced

8. Dementia

• Subjects who have other life threatening and debilitating systemic diseases

Note: Additional criteria may apply

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Disease
• Corneal Diseases
• Glaucoma
• Retinal Disease
• Retinal Diseases

Locations

Country	Name	City	State
United States	WCCT Global Opthalmology Research Center	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal thickness	Time frame is the maximum duration of hospital stay	Approximately four hours	No
Primary	Optic Disc Analysis	Time frame is the maximum duration of hospital stay	Approximately four hours	No
Primary	Corneal Thickness	Time frame is the maximum duration of hospital stay	Approximately four hours	No