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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
Must not have
Glaucoma filtering devices or trabeculectomies
History of previous corneal transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 130 weeks
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery for glaucoma.
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I have had a corneal transplant in the past.
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I have had cross-linking treatment before.
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I have a non-healing sore on the surface of my eye that's been there for over 6 weeks.
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My glaucoma is not under control.
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I do not have a fever or an ongoing infection treated with antibiotics.
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My eye is receiving treatment.
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My cornea lacks normal sensation.
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I have cancer in or around my eye.
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I am a pre-menopausal woman not using birth control like IUDs, pills, or condoms with spermicide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 130 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~130 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
• Keratometric astigmatism with Pentacam Schiempflug imaging at 130 weeks post-surgery.
Secondary study objectives
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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently participating in another medical study or trial at the same time.I have had surgery for glaucoma.I agree not to undergo any additional eye surgeries during the study.I have had a corneal transplant in the past.I have had cross-linking treatment before.I have a non-healing sore on the surface of my eye that's been there for over 6 weeks.I do not have significant eyelid issues that could affect the study.You have vision in only one eye.My glaucoma is not under control.I do not have a fever or an ongoing infection treated with antibiotics.My eye is receiving treatment.I am between 18 and 50 years old.My cornea lacks normal sensation.I am older than 50 years.I have keratoconus needing a cornea transplant but haven't had one yet.I have cancer in or around my eye.I am a pre-menopausal woman not using birth control like IUDs, pills, or condoms with spermicide.I am receiving or need systemic treatment.I have not had an eye infection in the last 30 days.You have a history of Stevens-Johnson syndrome or ocular pemphigoid.
Research Study Groups:
This trial has the following groups:- Group 1: Non-cross-linked donor corneal tissue for keratoplasty
- Group 2: Ex vivo cross linking of donor corneal tissue
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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