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Keratoconus, Corneal Diseases and Transplant Registry

NCT ID: NCT04164407

Last Updated: 2020-12-29

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

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Diseases Keratoconus Corneal Ulcer Corneal Trauma Corneal Dystrophies

Keywords

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Pseudophakic and aphakic bullous keratopathy Ophthalmology Cornea Keratoconus Cornea transplant Corneal dystrophies Crosslinking

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent Daien, MD, PhD, HDR

Role: STUDY_DIRECTOR

University Hospitals of Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent Daien, MD, PhD, HDR

Role: CONTACT

Phone: 67336966

Email: [email protected]

Fanny Babeau, MD

Role: CONTACT

Phone: 7335663

Email: [email protected]

Facility Contacts

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Vincent Daien, MD, PhD, HDR

Role: primary

Hannah Crowdy

Role: backup

Other Identifiers

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RECHMPL19_0500

Identifier Type: -

Identifier Source: org_study_id