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Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism

Primary Purpose

Hyperopia, Hyperopic Astigmatism

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
riboflavin ophthalmic solution, 0% dextran
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Laser-assisted in situ keratomileusis
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring hyperopia, hyperopic astigmatism, cross-linking

Eligibility Criteria

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

Inclusion Criteria:

  • 1. Be at least 18 years of age, male or female, of any race;
  • 2. Provide written informed consent and sign a HIPAA form;
  • 3. Willingness and ability to follow all instructions and comply with the schedule for study visits;
  • 4. Undergoing bilateral LASIK for the correction of hyperopia or hyperopic astigmatism;
  • 5. Intended treatment > +2.0 diopters (D) to < +6.0 D of MRSE hyperopia or hyperopia with astigmatism, with up to +6.0 D of spherical component and up to 5.0 D of astigmatic component (all refractions measured at the spectacle plane);
  • 6. Bilateral physiologic hyperopia;
  • 7. For females capable of becoming pregnant, agree to have urine pregnancy testing performed at visit 2 prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the visit 2 and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  • 8. Best spectacle corrected visual acuity (BSCVA) of 70 letters or more on ETDRS chart;
  • 9. Difficulty maintaining uncorrected visual acuity (UCVA) of at least 70 letters on ETDRS chart as evidenced by need for constant contact lens or spectacle wear;
  • 10. Less than 0.75 D spherical equivalent difference between cycloplegic and manifest refractions;
  • 11. Stable refraction (a difference of 0.50 D or less in MRSE) for the last 12 months, objectively documented (by previous clinical records, prescriptions, etc.), exclusive of changes determined by the investigator to be due to unmasking latent hyperopia;
  • 12. Normal corneal topography, as judged by the investigator;
  • 13. Removal of contact lenses for the required period of time prior to the screening refraction:

    1. Soft - 3 Days
    2. Soft Toric - 2 Weeks
    3. Rigid gas permeable - 2 Weeks
  • 14. Contact Lens Wearers Only: Must demonstrate a stable refraction (a difference of 0.50 D or less) as determined by MRSE on two consecutive exam dates performed at least 7 days apart. A contact lens wearer is defined as someone who has worn contact lenses in either eye in the last 30 days.

Exclusion Criteria:

  • 1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
  • 2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study;
  • 3. Eyes which are aphakic;
  • 4. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
  • 5. Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study (e.g., dry eyes, immuno- compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.);
  • 6. Systemic medications that may confound the outcome of the study or increase the risk to the subject, including but not limited to steroids, antimetabolites, etc.;
  • 7. Ocular condition that may predispose the subject to future complications, for example:

    1. History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.);
    2. Evidence of retinal vascular disease;
    3. Keratoconus or keratoconus suspect;
    4. Glaucoma or glaucoma suspect by exam findings and/or family history;
  • 8. Previous intraocular or corneal surgery including prior refractive surgery that might confound the outcome of the study or increase the risk to the subject;
  • 9. An increased risk for developing strabismus post-treatment;
  • 10. Subjects with nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests;
  • 11. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment;
  • 12. Corneal thickness <470 microns as measured by Pentacam;
  • 13. The Investigator may exclude or discontinue any subject for any sound medical reason;
  • 14. The subject should not have participated in any investigational drug or device study within 30 days of screening or be concurrently enrolled in another investigational drug or device study.

Sites / Locations

  • Gordon -Weiss-Schanzlin Vision Institute
  • Ophthalmic Consultants of Boston
  • Hersh Vision Group
  • Vance Thompson Vision
  • See Clearly Vision

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LASIK followed by Cross-linking (Continuous Wave)

LASIK followed by Cross-linking (Pulsed)

LASIK Only

Arm Description

Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.

Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.

Eyes assigned to this arm will receive standard LASIK with no cross-linking.

Outcomes

Primary Outcome Measures

MRSE Regression
The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
MRSE Regression
The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2013
Last Updated
April 22, 2021
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01893359
Brief Title
Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
Official Title
A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of LASIK With Cross-linking Performed With the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution) Compared to LASIK Alone for Hyperopia and Hyperopic Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Hyperopic Astigmatism
Keywords
hyperopia, hyperopic astigmatism, cross-linking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LASIK followed by Cross-linking (Continuous Wave)
Arm Type
Experimental
Arm Description
Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
Arm Title
LASIK followed by Cross-linking (Pulsed)
Arm Type
Experimental
Arm Description
Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
Arm Title
LASIK Only
Arm Type
Placebo Comparator
Arm Description
Eyes assigned to this arm will receive standard LASIK with no cross-linking.
Intervention Type
Drug
Intervention Name(s)
riboflavin ophthalmic solution, 0% dextran
Other Intervention Name(s)
Photrexa ZD
Intervention Type
Device
Intervention Name(s)
UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Other Intervention Name(s)
KXL System
Intervention Type
Device
Intervention Name(s)
UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Other Intervention Name(s)
KXL System
Intervention Type
Procedure
Intervention Name(s)
Laser-assisted in situ keratomileusis
Other Intervention Name(s)
LASIK
Primary Outcome Measure Information:
Title
MRSE Regression
Description
The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
Time Frame
one week to six months
Title
MRSE Regression
Description
The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
Time Frame
one week to twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Be at least 18 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form; 3. Willingness and ability to follow all instructions and comply with the schedule for study visits; 4. Undergoing bilateral LASIK for the correction of hyperopia or hyperopic astigmatism; 5. Intended treatment > +2.0 diopters (D) to < +6.0 D of MRSE hyperopia or hyperopia with astigmatism, with up to +6.0 D of spherical component and up to 5.0 D of astigmatic component (all refractions measured at the spectacle plane); 6. Bilateral physiologic hyperopia; 7. For females capable of becoming pregnant, agree to have urine pregnancy testing performed at visit 2 prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the visit 2 and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); 8. Best spectacle corrected visual acuity (BSCVA) of 70 letters or more on ETDRS chart; 9. Difficulty maintaining uncorrected visual acuity (UCVA) of at least 70 letters on ETDRS chart as evidenced by need for constant contact lens or spectacle wear; 10. Less than 0.75 D spherical equivalent difference between cycloplegic and manifest refractions; 11. Stable refraction (a difference of 0.50 D or less in MRSE) for the last 12 months, objectively documented (by previous clinical records, prescriptions, etc.), exclusive of changes determined by the investigator to be due to unmasking latent hyperopia; 12. Normal corneal topography, as judged by the investigator; 13. Removal of contact lenses for the required period of time prior to the screening refraction: Soft - 3 Days Soft Toric - 2 Weeks Rigid gas permeable - 2 Weeks 14. Contact Lens Wearers Only: Must demonstrate a stable refraction (a difference of 0.50 D or less) as determined by MRSE on two consecutive exam dates performed at least 7 days apart. A contact lens wearer is defined as someone who has worn contact lenses in either eye in the last 30 days. Exclusion Criteria: 1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components; 2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study; 3. Eyes which are aphakic; 4. Eyes which are pseudophakic and do not have a UV blocking lens implanted; 5. Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study (e.g., dry eyes, immuno- compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.); 6. Systemic medications that may confound the outcome of the study or increase the risk to the subject, including but not limited to steroids, antimetabolites, etc.; 7. Ocular condition that may predispose the subject to future complications, for example: History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.); Evidence of retinal vascular disease; Keratoconus or keratoconus suspect; Glaucoma or glaucoma suspect by exam findings and/or family history; 8. Previous intraocular or corneal surgery including prior refractive surgery that might confound the outcome of the study or increase the risk to the subject; 9. An increased risk for developing strabismus post-treatment; 10. Subjects with nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests; 11. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment; 12. Corneal thickness <470 microns as measured by Pentacam; 13. The Investigator may exclude or discontinue any subject for any sound medical reason; 14. The subject should not have participated in any investigational drug or device study within 30 days of screening or be concurrently enrolled in another investigational drug or device study.
Facility Information:
Facility Name
Gordon -Weiss-Schanzlin Vision Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Hersh Vision Group
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
See Clearly Vision
City
McLean
State/Province
Virginia
ZIP/Postal Code
22102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism

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