Epi-ON corneal crosslinking with UVA for people with Down syndrome and corneal ectasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants aged 8 and older with Down syndrome and a diagnosis of keratoconus, pellucid marginal degeneration, forme fruste keratoconus, or other corneal ectasia will receive Epi-ON corneal collagen crosslinking using riboflavin eye drops and UVA exposure. The procedure leaves the corneal epithelium intact (Epi-ON) and is given at specialized Woolfson Eye Institute locations. Subjects will return for up to seven in-office visits over six months for vision and corneal imaging tests to monitor safety and any change in disease progression. The main outcome is whether the treatment slows or halts worsening of corneal shape and vision.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be at least 8 years of age or older, male or female, of any race.
2. Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedures.
3. Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme fruste keratoconus based on topography, tomography, and slit lamp examination.
4. Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. If the subject has impaired consent capacity, determined by the consenter, the consent form must be signed by the subject's legally authorized representative on behalf of the subject.
5. Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)
6. Be willing and able to follow all instructions to the best of his/her abilities and comply with the schedule for follow-up visits.

Exclusion Criteria:

1. Normal corneal topography.
2. A history of previous corneal transplant in the study eye.
3. Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:

   1. History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
   2. Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking procedure.
5. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
6. Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
7. If female, pregnant, lactating or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. \[NOTE: If female and capable of becoming pregnant, must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. \]

7\. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.

8\. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.

9\. Inability to return for required postoperative examinations. 10. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.

Where it's running

• Woolfson Eye Institute
  Atlanta, Georgia, United States Recruiting
• Woolfson Eye Institute
  Atlanta, Georgia, United States Recruiting
• Woolfson Eye Institute
  Canton, Georgia, United States Recruiting
• Woolfson Eye Institute
  Cumming, Georgia, United States Recruiting
• Woolfson Eye Institute
  Douglasville, Georgia, United States Recruiting
• Woolfson Eye Institute
  Lawrenceville, Georgia, United States Recruiting

Study contacts

• Study coordinator: LuAnn Bryant
• Email: lbryant@woolfsoneye.com
• Phone: 770-804-1684

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epi-ON corneal crosslinking: 18-minute versus 24-minute UVA exposure for ectatic corneas

  This test compares whether an 18-minute or a 24-minute Epi-ON corneal crosslinking procedure better slows progression in people with keratoconus or other ectatic corneal conditions.

  Recruiting at 12 sites Phase 3 Woolfson Eye Institute · Atlanta, Georgia and 11 other locations · NCT07124910

• Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia

  This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.

  Recruiting Phase 2/3 Price Vision Group · Indianapolis, Indiana · NCT07841470

• Brillouin hydration mapping to study cornea health

  Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07780890

• Same-day bilateral corneal cross-linking for keratoconus

  This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.

  Recruiting Phase 4 Glaukos Corporation · Westerville, Ohio · NCT07629557

• A Smart Aperture Lens to Help Keratoconus and Presbyopia

  This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.

  Recruiting at 2 sites Azalea Vision · Antwerp and 1 other locations · NCT07559188

• GLK-221 eye drops for keratoconus

  This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.

  Recruiting Phase 2 Glaukos Corporation · Westerville, Ohio · NCT07400952

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.