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Specular Microscope
Non-Pathologic Adults age 18-28 yrs for Corneal Endothelial Cell Loss
N/A
Waitlist Available
Research Sponsored by Topcon Medical Systems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to evaluate any adverse events found during the clinical study.
Eligible Conditions
- Corneal Endothelial Cell Loss
- Endothelial Cell Loss Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pathologic Adults age 29-80 yrsExperimental Treatment2 Interventions
Pathologic Adults age 29-80 yrs
Group II: Non-Pathologic Adults age 29-80 yrsExperimental Treatment2 Interventions
Non-Pathologic Adults age 29-80 yrs
Group III: Non-Pathologic Adults age 18-28 yrsExperimental Treatment2 Interventions
Non-Pathologic Adults age 18-28 yrs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Konan Specular Microscope CELLCHEK XL
2014
N/A
~150
Topcon Specular Microscope SP-1P
2014
N/A
~150
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Who is running the clinical trial?
Topcon Medical Systems, Inc.Lead Sponsor
26 Previous Clinical Trials
3,274 Total Patients Enrolled
1 Trials studying Corneal Endothelial Cell Loss
76 Patients Enrolled for Corneal Endothelial Cell Loss
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