Treatment for Keratoconus with INTACS Inserts

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

This clinical trial evaluates the use of INTACS prescription inserts for patients with keratoconus, a condition that causes progressive vision deterioration. The procedure involves surgically placing two clear INTACS inserts into the cornea to improve vision by reshaping the cornea. Patients will undergo a series of pre-operative and post-operative assessments to monitor visual acuity and corneal health over a 12-month period. The inserts are made from a biomedical material and are designed to be minimally invasive, allowing for outpatient treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.

Exclusion Criteria:

Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site;

Patients with collagen vascular, autoimmune or immunodeficiency disease;

Pregnant or nursing patients;

Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications;

Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).

Where it's running

• UTSW Medical Center at Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Steven Verity, MD — UTSW Medical Center at Dallas
• Study coordinator: Peter Chen, PhD
• Email: Peter.Chen@UTSouthwestern.edu
• Phone: 214-648-3837

Similar studies

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

• 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

• Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus

  This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.

  Recruiting Instituto de Oftalmología Fundación Conde de Valenciana · Mexico City, Mexico City · NCT07372911

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.