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Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Primary Purpose

Keratoconus, Post-Refractive Ectasia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Riboflavin

UVX light

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Ectasia, cross linking, collagen cross linking

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

10 years of age or older
Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
1. An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
2. An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
Subjects with keratoconus diagnosis only:
a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
Signed written informed consent

Exclusion Criteria:

1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
7. Pregnancy (including plan to become pregnant) or lactation during the course of the study

Sites / Locations

Price Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Riboflavin 0.1% eyedrops every 5 minutes

Riboflavin 0.1% eyedrops every 2 minutes

Arm Description

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).

Outcomes

Primary Outcome Measures

Change in Maximum Keratometry From Baseline to 6 Months After Treatment

Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.

Secondary Outcome Measures

Pachymetry

Minimum corneal thickness measured by corneal tomography

Corrected Distance Visual Acuity (CDVA)

Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.

Uncorrected Distance Visual Acuity (UDVA)

Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.

Full Information

NCT ID

NCT01143389

First Posted

June 11, 2010

Last Updated

May 3, 2018

Sponsor

Price Vision Group

1. Study Identification

Unique Protocol Identification Number

NCT01143389

Brief Title

Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Official Title

Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 30, 2017 (Actual)

Study Completion Date

August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Price Vision Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.

Detailed Description

The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus, Post-Refractive Ectasia

Keywords

Keratoconus, Ectasia, cross linking, collagen cross linking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

510 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Riboflavin 0.1% eyedrops every 5 minutes

Arm Type

Active Comparator

Arm Description

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).

Arm Title

Riboflavin 0.1% eyedrops every 2 minutes

Arm Type

Active Comparator

Arm Description

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Intervention Description

Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.

Intervention Type

Device

Intervention Name(s)

UVX light

Intervention Description

UVX 365 nm wavelength light source is applied with continued application of riboflavin.

Primary Outcome Measure Information:

Title

Change in Maximum Keratometry From Baseline to 6 Months After Treatment

Description

Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pachymetry

Description

Minimum corneal thickness measured by corneal tomography

Time Frame

6 months

Title

Corrected Distance Visual Acuity (CDVA)

Description

Time Frame

6 months

Title

Uncorrected Distance Visual Acuity (UDVA)

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 10 years of age or older Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization: An increase of ≥ 1.00 D in the steepest keratometry value (or sim K) An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia. Subjects with keratoconus diagnosis only: a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks Signed written informed consent Exclusion Criteria: 1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity. 2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example: a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated. 5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing. 7. Pregnancy (including plan to become pregnant) or lactation during the course of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis W Price, MD

Organizational Affiliation

Price Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18811118

Citation

Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.

Results Reference

background

PubMed Identifier

18471635

Citation

Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.

Results Reference

background

PubMed Identifier

16952090

Citation

Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. doi: 10.1177/112067210601600405.

Results Reference

background

PubMed Identifier

16765803

Citation

Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.

Results Reference

background

PubMed Identifier

29203068

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.

Results Reference

derived

Links:

URL

http://www.pricevisiongroup.com/

Description

Price Vision Group Website

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Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

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