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Progressive Keratoconus or Ectasia Treatment Plan

Primary Purpose

Keratoconus, Ectasia

Status

No longer available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Riboflavin Solution

UV-X Illumination System

About this trial

This is an expanded access trial for Keratoconus focused on measuring Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK (laser in situ keratomileusis), pellucid marginal degeneration, irregular astigmatism

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment:

For Keratoconus and Post Refractive Surgery Ectasia:

16 years of age or older
Having a diagnosis of keratoconus with one or more of the following changes over a period of 24 months or less.
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.
Presence of central or inferior steepening on the Pentacam map.
Axial topography consistent with keratoconus
Slit lamp findings associated with keratoconus must be documented:
- Fleischer ring
- Vogt striae
- Corneal thinning
- Corneal scarring
Contact Lens Wearers Only: Removal of contact lenses are required prior to the screening
Signed written informed consent

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this treatment:

No evidence of progression.
Excessively thin corneas.
Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
2. Clinically significant corneal scarring in the proposed treatment zone
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
A known sensitivity to treatment medications
Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.

Sites / Locations

Edward Harkness Eye Institute-Columbia University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01384773

First Posted

June 27, 2011

Last Updated

February 7, 2023

Sponsor

Stephen Trokel

1. Study Identification

Unique Protocol Identification Number

NCT01384773

Brief Title

Progressive Keratoconus or Ectasia Treatment Plan

Official Title

Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia

Study Type

Expanded Access

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephen Trokel

4. Oversight

5. Study Description

Brief Summary

Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and post surgical ectasia is an iatrogenic condition. These diseases are characterized by weakening of the front part of the eye that causes thinning and distortion. This distortion results in unevenness of the cornea and produces progressive near-sightedness and irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give enough vision, the the investigators use rigid contact lenses to create an artificial front eye surface. This improves visual acuity in many patients although they eventually fail either because they cannot be tolerated or the surface irregularity has become so severe that they are rejected. At this stage there is usually thinning and loss of clarity of the eye. There has been no treatment for this other than corneal transplantation, a complex surgical procedure with a significant complication rate and a delay in visual recovery. The treatment the investigators wish to perform strengthens the front of the eye by a chemical reaction using light and riboflavin. This technique has been studied over a decade and is widely used throughout the world. The FDA approved multicenter American clinical study is being analyzed in anticipation of its submission to the FDA for PreMarket approval. Because this is a progressive condition, the investigators wish to be able to offer this on a limited basis to patients in need with vision loss. Any treatment that can delay or prevent corneal transplantation is of great benefit. The investigators believe the evidence is compelling that this treatment is the sole alternative to surgical transplantation.

Detailed Description

Potential candidates will undergo a complete eye examination to determine their eligibility for treatment. Eligible subjects will be prepared for treatment in accordance with the instructions for use in the UV-X™ Illumination System Operator's Manual, including the administration of the riboflavin and preoperative medications (e.g. topical anesthetics). Prescriptions for postoperative medications and written postoperative instructions will be given to each subject and reviewed prior to discharge. All subjects will have follow-up examination at 1 day, 1 week, 3 month and 6 month.

6. Conditions and Keywords

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

Keratoconus, Ectasia

Keywords

Keratoconus, Ectasia, UVA light, riboflavin, post-LASIK (laser in situ keratomileusis), pellucid marginal degeneration, irregular astigmatism

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Riboflavin Solution

Other Intervention Name(s)

Medio-Cross Riboflavin 0.1% ophthalmic solution

Intervention Description

This solution is used to saturate the corneal stroma prior to its photochemical activation by the IROC UV-X illuminator.

Intervention Type

Device

Intervention Name(s)

UV-X Illumination System

Other Intervention Name(s)

IROC UV-X System

Intervention Description

IROC UV-X irradiation system creates a uniform 11 mm circle of UVA light that is focused onto the corneal surface. This system is designed to irradiate the riboflavin saturated cornea with a uniform field of UVA light centered at 365 nm.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment: For Keratoconus and Post Refractive Surgery Ectasia: 16 years of age or older Having a diagnosis of keratoconus with one or more of the following changes over a period of 24 months or less. 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. Presence of central or inferior steepening on the Pentacam map. Axial topography consistent with keratoconus Slit lamp findings associated with keratoconus must be documented: Fleischer ring Vogt striae Corneal thinning Corneal scarring Contact Lens Wearers Only: Removal of contact lenses are required prior to the screening Signed written informed consent Exclusion Criteria: All subjects meeting any of the following criteria will be excluded from this treatment: No evidence of progression. Excessively thin corneas. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the proposed treatment zone A history of chemical injury or delayed epithelial healing in the eye(s) to be treated. A known sensitivity to treatment medications Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen L Trokel, MD

Organizational Affiliation

Columbia University, Department of Ophthalmology, College of Physicians and Surgeons

Official's Role

Principal Investigator

Facility Information:

Facility Name

Edward Harkness Eye Institute-Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

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

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Progressive Keratoconus or Ectasia Treatment Plan

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