RecruitingPhase 2Phase 3NCT03922542

Comparison of Standard vs. Accelerated Corneal Crosslinking

Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia


Sponsor

Price Vision Group

Enrollment

510 participants

Start Date

Apr 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.


Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial, titled "Comparison of Standard vs. Accelerated Corneal Crosslinking" (study ID: NCT03922542), is comparing two methods of performing corneal cross-linking (CXL) — a procedure used to halt the progression of keratoconus or corneal ectasia (a thinning and bulging of the cornea). The standard method delivers UV light over a longer period at lower intensity, while the accelerated method delivers a higher intensity for a shorter time. Both methods use riboflavin drops to sensitize the cornea. Researchers want to know if the faster approach is as effective and safe as the standard one. The study is open to patients aged 10 and older with documented keratoconus or corneal ectasia following refractive surgery, with adequate corneal thickness to safely perform the procedure. People with corneal conditions that could complicate healing or who are pregnant are excluded. You may be eligible if you: - Are 10 years of age or older - Have documented keratoconus or corneal ectasia after refractive surgery - Have sufficient corneal thickness to safely undergo cross-linking You may NOT be eligible if you: - Have insufficient corneal thickness - Have an ocular condition that predisposes your eye to complications - Have a history of chemical injury or problems with delayed corneal healing - Have a known sensitivity to treatment medications - Are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTriboflavin 0.1%

Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes

COMBINATION_PRODUCTRiboflavin 0.1%

Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes


Locations(1)

Price Vision Group

Indianapolis, Indiana, United States

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NCT03922542


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