Assessing Patient Engagement in Keratoconus Clinical Research

February 23, 2024 updated by: Power Life Sciences Inc.

Exploring Enrollment and Engagement Trends in Individuals Managing Keratoconus: A Comprehensive Examination of Data on Keratoconus Clinical Trials

This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.

In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with keratoconus who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Description

Inclusion Criteria:

  • Signed Written Informed Consent
  • Aged ≥ 18 years old
  • No prior treatment for keratoconus

Exclusion Criteria:

  • Participant is actively receiving study therapy in another
  • Inability to provide written informed consent
  • Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients who decide to join in a keratoconus clinical trial
Time Frame: 3 months
3 months
Number of keratoconus patients who remain in clinical trial until completion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Investigators

  • Study Director: Michael B Gill, Power Life Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54335073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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