NCT07474870

Brief Summary

Measuring quality of vision and quality of life outcomes using a validated questionnaire in participants undergoing CTAK surgery for corneal ectasia

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
54mo left

Started May 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026Jan 2031

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

March 11, 2026

Last Update Submit

April 21, 2026

Conditions

KeratoconusCorneal Ectasia

Keywords

CTAKCorneal Ectasia

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    Preoperative and postoperative questionnaire

    One year

Study Arms (1)

Patient reported outcomes after CTAK surgery

OTHER

All subjects will complete preoperative and postoperative questionnaires

Behavioral: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical ExamBEHAVIORAL

Patient reported outcomes of CTAK surgery

Patient reported outcomes after CTAK surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal Ectasia and Keratoconus

You may not qualify if:

  • Excessively thin cornea
  • Significant corneal scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Central Study Contacts

Edward Manche, MD

CONTACT

16504987020edward.manche@stanford.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Preoperative and postoperative questionnaire
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)