CompletedNot Applicable

Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements

United States65 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non-Pathologic Adults (29-80 years old): * Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed; * Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; * Subjects who agree to participate in the study. Inclusion Criteria -Pathologic Adults (29-80 years old) * Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed; * Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; * Subjects who agree to participate in the study; * At least one eye with any of the following conditions: * History of post-op surgical trauma including Pseudophakic or Aphakic bullous keratopathy; * History of corneal transplant; * Physical injury or trauma to the cornea; * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophies) * Keratoconus; * Long term PMMA contact lens use (greater than 3 years). Exclusion Criteria -Non-Pathologic Young Adults (18-28 years old) and Non Pathologic Adults (29-80 years old) * History of corneal transplant; * Long term Fuch's dystrophy (and other corneal endothelial dystrophies); * Keratoconus; * Guttata; * Diabetes mellitus …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Corneal endothelial cell density

Timeframe: Single time point - 1 day

Coefficient of variation of endothelial cell area

Timeframe: Single time point - 1 day

Corneal endothelial cell % hexagonality

Timeframe: Single time point - 1 day

Central corneal thickness

Timeframe: Single time point - 1 day

Trial details

NCT IDNCT02138266

SponsorTopcon Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-03

View on ClinicalTrials.gov More Corneal Endothelial Cell Loss trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.