Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus
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
- The protocol lists: Riboflavin Ophthalmic Solutions, UV-A Irradiation System.
- Who it may be relevant to
- Registry conditions: Keratoconus. Basic parameters: from 13 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
Single-arm, Multi-center Study to Evaluate the Safety and Feasibility of Bilateral Epithelium-on Corneal Collagen Cross-linking With Epioxa™ HD/Epioxa™ and UV-A Irradiation Using the O2n™ System and Supplemental Oxygen Using the Boost Goggles® in Subjects With Keratoconus
Overview
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
Interventions
- Drug Riboflavin Ophthalmic Solutions
Riboflavin Ophthalmic Solutions - Device UV-A Irradiation System
O2n UV-A Irradiation System
Primary outcome measures
- Successful completion of bilateral epithelium-on corneal collagen cross-linking. [Time frame: Approximately 2.5 Months]
Eligibility criteria
Inclusion criteria
- Provide written informed consent
- Willing and able to comply with study instructions and follow-up visits
- Diagnosis of keratoconus in each eye
Exclusion criteria
- Known allergy or sensitivity to study medications
- History of corneal disease
- Prior corneal cross-linking in either eye
- Pregnant, nursing, or planning pregnancy during the study period
- Participated in other investigational drug or device trial within 30 days of the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Glaukos Investigative Site — Westerville
Identifiers
NCT: NCT07629557 · GLK-202-05