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NCT06288737 Clinical Trial

Assessing Patient Engagement in Keratoconus Clinical Research

Keratoconus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06288737
Other study ID # 54335073
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2025
Est. completion date March 2027

Study information
Verified date February 2024
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date March 2027
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Aiello F, Gallo Afflitto G, Ceccarelli F, Garzione F, Pocobelli G, Pinci C, Di Lorenzo G, Siracusano A, Nucci C. Keratoconus and Personality Traits: A Case-Control Study. Cornea. 2024 Feb 1;43(2):237-244. doi: 10.1097/ICO.0000000000003284. Epub 2023 Apr 5. — View Citation

Kandel H, Pesudovs K, Nguyen V, Chen JY, Poon A, Mills R, Watson SL. Patient-Reported Outcomes in Keratoconus: A Save Sight Keratoconus Registry Study. Cornea. 2023 May 1;42(5):590-597. doi: 10.1097/ICO.0000000000003119. Epub 2022 Aug 24. — View Citation

Moran S, Gomez L, Zuber K, Gatinel D. A Case-Control Study of Keratoconus Risk Factors. Cornea. 2020 Jun;39(6):697-701. doi: 10.1097/ICO.0000000000002283. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to join in a keratoconus clinical trial 3 months
Primary Number of keratoconus patients who remain in clinical trial until completion 12 months
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