OCT Agreement and Crossed Precision Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Retinal Disease Corneal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal eyes

Eyes without pathology.

No interventions assigned to this group

Glaucoma

Eyes with Glaucoma.

No interventions assigned to this group

Retinal

Eyes with Retinal Disease.

No interventions assigned to this group

Corneal

Eyes with corneal disease including a kerato-refractive group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who do not have pathology in both eyes

* Subjects who have a glaucoma diagnosis

* 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

* Subjects who has one of these diagnosis:

1. Post status LASIK surgery
2. Keratoconus
3. Other corneal dystrophies or degenerations.

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes