Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)

Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)

The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent.

Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25.

This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice.

A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.

•Methods:

Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier.

A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice.

This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become.

•Discussion:

The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care.

In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.

Study Overview

• Status: Unknown
• Conditions: Corneal Diseases; Keratoconus; Corneal Ulcer; Corneal Trauma; Corneal Dystrophies

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Fanny Babeau, MD; Phone Number: 33 7335663; Email: f-babeau@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: Hannah Crowdy; Phone Number: 33 7335663; Email: h-crowdy@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with corneal disease, including keratoconus and / or corneal transplant.

Description

Inclusion Criteria:

• Suffering from a corneal disease
• Undergoing treatment in the Ophthalmology department of the CHU Montpellier
• Has been presented with an Opt-Out consent form

Exclusion Criteria:

• Expressed a desire to not be included in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual Acuity	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment(s) received	Treatment(s) received	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cornea; Ophthalmology; Keratoconus; Crosslinking; Pseudophakic and aphakic bullous keratopathy; Cornea transplant; Corneal dystrophies
• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Eye Diseases; Wounds and Injuries; Genetic Diseases, Inborn; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases, Hereditary; Keratitis; Eye Infections; Facial Injuries; Eye Injuries; Keratoconus; Corneal Dystrophies, Hereditary; Corneal Diseases; Corneal Ulcer; Corneal Injuries
• Other Study ID Numbers: RECHMPL19_0500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No