Keratoconus, Corneal Diseases and Transplant Registry

NCT04164407 | Unknown

• 1 other identifier: RECHMPL19_0500
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Diseases; Keratoconus; Corneal Ulcer; Corneal Trauma; Corneal Dystrophies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Visual Acuity

  1 day

Secondary Outcomes (1)

• Treatment(s) received

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Expressed a desire to not be included in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Corneal Diseases; Keratoconus; Corneal Ulcer; Corneal Injuries; Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Infections; Infections; Keratitis; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vincent Daien, MD, PhD, HDR

  University Hospitals of Montpellier

  STUDY DIRECTOR

Central Study Contacts

Vincent Daien, MD, PhD, HDR

CONTACT

67336966; v-daien@chu-montpellier.fr

Fanny Babeau, MD

CONTACT

7335663; f-babeau@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)