Assessing Patient Engagement in Keratoconus Clinical Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Keratoconus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring Enrollment and Engagement Trends in Individuals Managing Keratoconus: A Comprehensive Examination of Data on Keratoconus Clinical Trials
Overview
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.
Primary outcome measures
- Rate of patients who decide to join in a keratoconus clinical trial [Time frame: 3 months]
- Number of keratoconus patients who remain in clinical trial until completion [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Power Life Sciences — San Francisco
Publications
- 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. PMID 32040008
- 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. PMID 36036705
- 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. PMID 37018764
Identifiers
NCT: NCT06288737 · 54335073