Comparison of Standard vs. Accelerated Corneal Crosslinking

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03922542
• Other study ID #: 2019-003
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 16, 2019
• Est. completion date: May 1, 2026

Study information

• Verified date: February 2024
• Source: Price Vision Group
• Contact: Marianne Price, PhD
• Phone: 317-814-2990
• Email: mprice[@]cornea.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Documented keratoconus or ectasia after refractive surgery

Exclusion Criteria:

• Insufficient corneal thickness
• Ocular condition that may predispose the eye to complications
• History of chemical injury or delayed epithelial healing
• Condition that would interfere with or prolong epithelial healing
• Known sensitivity to treatment medications
• Pregnancy

Related Conditions & MeSH terms

• Ectasia Corneal
• Keratoconus

Intervention

Combination Product:
• riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
• Riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Price Vision Group

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lautert J, Doshi D, Price FW Jr, Price MO. Corneal Epithelial Remodeling After Standard Epithelium-off Corneal Cross-linking in Keratoconic Eyes. J Refract Surg. 2018 Jun 1;34(6):408-412. doi: 10.3928/1081597X-20180402-03. — View Citation

Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2. — View Citation

Price MO, Feng MT, Price FW Jr. Patient satisfaction with epithelium-off corneal crosslinking. J Cataract Refract Surg. 2018 Mar;44(3):323-328. doi: 10.1016/j.jcrs.2017.12.023. Epub 2018 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximum keratometry	assessed by corneal tomography	6 months
Secondary	Change in corrected distance visual acuity	assessed with Snellen chart	6 months
Secondary	Change in uncorrected distance visual acuity	assessed with Snellen chart	6 months