Comparison of Standard vs. Accelerated Corneal Crosslinking
Sponsor
Price Vision Group (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03922542
Collaborator
(none)
510
1
2
84.5
6
Study Details
Study Description
Brief Summary
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
510 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
Actual Study Start Date
:
Apr 16, 2019
Anticipated Primary Completion Date
:
May 1, 2026
Anticipated Study Completion Date
:
May 1, 2026
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Accelerated Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes |
Combination Product: riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
|
Active Comparator: Standard Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes |
Combination Product: Riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
|
Outcome Measures
Primary Outcome Measures
- Change in maximum keratometry [6 months]
assessed by corneal tomography
Secondary Outcome Measures
- Change in corrected distance visual acuity [6 months]
assessed with Snellen chart
- Change in uncorrected distance visual acuity [6 months]
assessed with Snellen chart
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Price Vision Group | Indianapolis | Indiana | United States | 46260 |
Sponsors and Collaborators
- Price Vision Group
Investigators
- Principal Investigator: Francis W Price, Jr., MD, Price Vision Group
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
Responsible Party:
Price Vision Group
ClinicalTrials.gov Identifier:
NCT03922542
Other Study ID Numbers:
- 2019-003
First Posted:
Apr 22, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: