KeratoconusNCT06288737
Assessing Patient Engagement in Keratoconus Clinical Research
An observational study of Keratoconus, run by Power Life Sciences Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with keratoconus who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Signed Written Informed Consent
- Aged ≥ 18 years old
- No prior treatment for keratoconus
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: 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.
- Conditions
- Keratoconus
- Keywords
- keratoconus
- Medical subject headings
- Keratoconus
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to join in a keratoconus clinical trial
Measured: 3 months
Number of keratoconus patients who remain in clinical trial until completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288737
- Sponsor's protocol ID
- 54335073
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32040008Kandel 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.
PubMed 36036705Aiello 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.
PubMed 37018764
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Enrollment and Engagement Trends in Individuals Managing Keratoconus: A Comprehensive Examination of Data on Keratoconus Clinical Trials
- ClinicalTrials.gov ID
- NCT06288737
- Acronym / sponsor ID
- 54335073
- Conditions
- Keratoconus
- Keywords
- keratoconus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with keratoconus who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Signed Written Informed Consent
- Aged ≥ 18 years old
- No prior treatment for keratoconus
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 32040008Moran 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.
- Background: PubMed 36036705Kandel 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.
- Background: PubMed 37018764Aiello 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill ((415) 900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to join in a keratoconus clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288737, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.