KeratoconusPhase 4CTAKNCT07474870
Outcomes of CTAK Surgery
A Phase 4 study testing Questionnaire and Physical Exam in people with Keratoconus and Corneal Ectasia, run by Stanford University at 1 site in United States.
Trial summary
Measuring quality of vision and quality of life outcomes using a validated questionnaire in participants undergoing CTAK surgery for corneal ectasia Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Questionnaire and Physical Exam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Jan 2031
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal Ectasia and Keratoconus
Who cannot join
- Excessively thin cornea
- Significant corneal scarring
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
Byers Eye Institute at Stanford
Palo Alto, California, 94303
Edward Manche, MD, 6508680912, edward.manche@stanford.edu
Edward Manche, MD
About this study
Official title: Outcomes of Corneal Tissue Addition for Keratoplasty (CTAK) in Patients With Ectatic Corneas
Measuring quality of vision and quality of life outcomes using a validated questionnaire in participants undergoing CTAK surgery for corneal ectasia
Read the detailed description
The investigators are measuring self-reported quality of vision and quality of life outcomes in participants undergoing CTAK surgery for corneal ectasia
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Questionnaire and Physical Exam
- Keywords
- CTAK, Corneal Ectasia
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamBehavioural
Patient reported outcomes of CTAK surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient reported outcomes after CTAK surgery | Other | All subjects will complete preoperative and postoperative questionnaires Receives: Behavioral: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Preoperative and postoperative questionnaire
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Preoperative and postoperative questionnaire
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward E. Manche, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474870
- Sponsor's protocol ID
- 78779
- Acronym
- CTAK
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Corneal Tissue Addition for Keratoplasty (CTAK) in Patients With Ectatic Corneas
- ClinicalTrials.gov ID
- NCT07474870
- Acronym / sponsor ID
- CTAK / 78779
- Conditions
- Keratoconus, Corneal Ectasia
- Keywords
- CTAK, Corneal Ectasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 16 Mar 2026 (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.
Measuring quality of vision and quality of life outcomes using a validated questionnaire in participants undergoing CTAK surgery for corneal ectasia
Detailed description
The investigators are measuring self-reported quality of vision and quality of life outcomes in participants undergoing CTAK surgery for corneal ectasia
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Preoperative and postoperative questionnaire
| Arm | Type | Receives |
|---|---|---|
| Patient reported outcomes after CTAK surgery | Other | Behavioral: Questionnaire and Physical ExamAll subjects will complete preoperative and postoperative questionnaires |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Corneal Ectasia and Keratoconus
Key exclusion criteria (2 listed)
- Excessively thin cornea
- Significant corneal scarring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamPatient reported outcomes of CTAK surgery | Behavioural | Patient reported outcomes after CTAK surgery |
Primary outcome
Questionnaire
Time frame: One year
Preoperative and postoperative questionnaire
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 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Questionnaire and Physical Exam in people with Keratoconus and Corneal Ectasia, run by Stanford University 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 1 inclusion and 2 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 24 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Edward Manche, MD (16504987020, edward.manche@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.