NCT02138266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

28 days

First QC Date

May 5, 2014

Last Update Submit

June 6, 2022

Conditions

Corneal Endothelial Cell Loss

Outcome Measures

Primary Outcomes (4)

  • Corneal endothelial cell density

    Single time point - 1 day

  • Coefficient of variation of endothelial cell area

    Single time point - 1 day

  • Corneal endothelial cell % hexagonality

    Single time point - 1 day

  • Central corneal thickness

    Single time point - 1 day

Study Arms (3)

Non-Pathologic Adults age 18-28 yrs

Non-Pathologic Adults age 18-28 yrs

Device: Topcon Specular Microscope SP-1PDevice: Konan Specular Microscope CELLCHEK XL

Non-Pathologic Adults age 29-80 yrs

Non-Pathologic Adults age 29-80 yrs

Device: Topcon Specular Microscope SP-1PDevice: Konan Specular Microscope CELLCHEK XL

Pathologic Adults age 29-80 yrs

Pathologic Adults age 29-80 yrs

Device: Topcon Specular Microscope SP-1PDevice: Konan Specular Microscope CELLCHEK XL

Interventions

Topcon Specular Microscope SP-1PDEVICE
Non-Pathologic Adults age 18-28 yrsNon-Pathologic Adults age 29-80 yrsPathologic Adults age 29-80 yrs
Konan Specular Microscope CELLCHEK XLDEVICE
Non-Pathologic Adults age 18-28 yrsNon-Pathologic Adults age 29-80 yrsPathologic Adults age 29-80 yrs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ophthalmology Practice

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • History of corneal transplant;
  • Long term Fuch's dystrophy (and other corneal endothelial dystrophies);
  • Keratoconus;
  • Guttata;
  • Diabetes mellitus type I or type II;
  • History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device;
  • All contact lens wearers;
  • Fixation problems which may prevent obtaining good quality SP-1P and CELLCHEK PLUS in either eye.
  • Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) SP-1P and KONAN CELLCHEK PLUS images in either eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 14, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)