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Procedure

Corneal Cross-Linking for Keratoconus (EVOKE Trial)

N/A

Waitlist Available

Led By Joseph B Ciolino

Research Sponsored by Joseph B. Ciolino, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study

Age ≥18 years but ≤50 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 130 weeks

Awards & highlights

EVOKE Trial Summary

This trialwill study if crosslinking donor corneas for keratoconus patients can reduce astigmatism & improve vision.

Who is the study for?

This trial is for individuals aged 18-50 with keratoconus requiring corneal transplantation, who haven't had a previous transplant or cross-linking, and have no history of certain eye conditions or systemic diseases. Participants must consent to study requirements and avoid additional corneal procedures during the study.Check my eligibility

What is being tested?

The trial tests if using donor corneas treated with Riboflavin and UV light (cross-linking) before transplant can improve vision and reduce astigmatism in keratoconus patients compared to transplants without this treatment.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of surgery, infection risk, inflammation, visual disturbances like glare or halos, sensitivity to light, and possibly rejection of the donor tissue.

EVOKE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to undergo any additional eye surgeries during the study.

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I am between 18 and 50 years old.

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I have keratoconus needing a cornea transplant but haven't had one yet.

EVOKE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 130 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~130 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 130 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.

Secondary outcome measures

Low-contrast BSCVA with ETDRS methodology at 130 weeks post-surgery

Manifest cylinder astigmatism at 130 weeks post-surgery

Uncorrected visual acuity (UCVA) 130 weeks post-surgery

+1 more

EVOKE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ex vivo cross linking of donor corneal tissueExperimental Treatment1 Intervention

Treatment Arm: The donor corneal tissue used in the PK or DALK procedures will previously undergo ex vivo crosslinking.

Group II: Non-cross-linked donor corneal tissue for keratoplastyPlacebo Group1 Intervention

Control Arm: The donor corneal tissue used in the PK or DALK procedures will not previously undergo ex vivo crosslinking.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joseph B. Ciolino, MDLead Sponsor

3 Previous Clinical Trials

122 Total Patients Enrolled

Joseph B CiolinoPrincipal InvestigatorMassachusetts Eye and Ear

Media Library

Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04584125 — N/A

Keratoconus Research Study Groups: Non-cross-linked donor corneal tissue for keratoplasty, Ex vivo cross linking of donor corneal tissue

Keratoconus Clinical Trial 2023: Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue Highlights & Side Effects. Trial Name: NCT04584125 — N/A

Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04584125 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this research endeavor?

"This research project is in need of 216 individuals who are between 18 and 50 years old, with a diagnosis of keratoconus."

Answered by AI

What medical purposes can be served through Ex vivo cross linking of donor corneal tissue?

"Ex vivo cross linking of donor corneal tissue is a useful therapeutic procedure for treating vitamin deficiencies, dry eye syndrome, and thrombosis."

Answered by AI

Does the research involve any geriatric volunteers?

"The age requirement for this medical experiment is between 18 and 50. For those under the legal age of consent, there are 19 studies available while 35 trials have been created to accommodate patients over 65 years old."

Answered by AI

Can you provide details on any prior experiments regarding the Ex vivo cross linking of donor corneal tissue?

"Presently, 3 active clinical trials for ex vivo cross linking of donor corneal tissue are in phase 3. Many of these investigations will be conducted within Boston, MA but there are also research centres across the country that are participating as well."

Answered by AI

Are there currently any open enrollment opportunities in this experiment?

"Data on clinicaltrials.gov indicates that, at present, this medical study is not recruiting patients. Initially published on December 1st 2023 and last edited on January 12th 2023, this trial has paused recruitment; however there are a total of 52 other trials actively enrolling participants currently."

Answered by AI

What is the target enrollment size for this trial?

"Unfortunately, no more patients can join this trial as recruitment has closed; the details were initially posted on December 1st 2023 and last updated on January 12th 2023. If you are still searching for other studies to participate in, 49 clinical trials related to keratoconus are open while 3 trials regarding Ex vivo cross linking of donor corneal tissue remain active."

Answered by AI

What favorable results is this trial expected to yield?

"Over the course of 130 weeks, this trial will be conducted to measure and evaluate treatment-related adverse effects like ocular infection, hindered wound healing processes, and graft rejection. Subsequent objectives include measuring manifest cylinder astigmatism at 130 weeks post-surgery with keratometry tests; determining uncorrected visual acuity (UCVA) 130 weeks after surgery; and examining low contrast BSCVA employing ETDRS methodology at a similar time frame with permeable contact lenses."

Answered by AI

Recent research and studies

American Journal of OphthalmologyJournal

Riboflavin/ultraviolet-a–induced Collagen Crosslinking for the Treatment of Keratoconus

Wollensak, Gregor, Eberhard Spoerl, and Theo Seiler. 2003. “Riboflavin/ultraviolet-a–induced Collagen Crosslinking for the Treatment of Keratoconus”. American Journal of Ophthalmology. Elsevier BV. doi:10.1016/s0002-9394(02)02220-1.

Survey of OphthalmologyJournal

Keratoconus and Related Noninflammatory Corneal Thinning Disorders

Krachmer, Jay H., Robert S. Feder, and Michael W. Belin. 1984. “Keratoconus and Related Noninflammatory Corneal Thinning Disorders”. Survey of Ophthalmology. Elsevier BV. doi:10.1016/0039-6257(84)90094-8.

clinicaltrials.govStudy

A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients

Joseph B. Ciolino, MD 2023. "A Randomized Clinical Trial of Ex Vivo Corneal Cross-Linking of Donor Keratoplasty Tissue for Keratoconus Used for Keratoplasty in Keratoconus Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584125.

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