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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893359
Recruitment Status : Terminated
First Posted : July 9, 2013
Results First Posted : October 24, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hyperopia
Hyperopic Astigmatism
Interventions Drug: riboflavin ophthalmic solution, 0% dextran
Device: UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
Device: UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Procedure: Laser-assisted in situ keratomileusis
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Hide Arm/Group 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.

riboflavin ophthalmic solution, 0% dextran

UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)

Laser-assisted in situ keratomileusis

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.

riboflavin ophthalmic solution, 0% dextran

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

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

Laser-assisted in situ keratomileusis

Period Title: Overall Study
Started 0 2 0
Completed 0 2 0
Not Completed 0 0 0
Arm/Group Title LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only Total
Hide Arm/Group 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.

riboflavin ophthalmic solution, 0% dextran

UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)

Laser-assisted in situ keratomileusis

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.

riboflavin ophthalmic solution, 0% dextran

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

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

Laser-assisted in situ keratomileusis

Total of all reporting groups
Overall Number of Baseline Participants 0 2 0 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 0 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 0 participants 2 participants
Female
1
  50.0%
1
  50.0%
Male
1
  50.0%
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 0 participants 2 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
2
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1.Primary Outcome
Title MRSE Regression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible.
Arm/Group Title LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Hide Arm/Group 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.

riboflavin ophthalmic solution, 0% dextran

UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)

Laser-assisted in situ keratomileusis

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.

riboflavin ophthalmic solution, 0% dextran

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

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

Laser-assisted in situ keratomileusis

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title MRSE Regression
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.
Arm/Group Title LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Hide Arm/Group 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.

riboflavin ophthalmic solution, 0% dextran

UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)

Laser-assisted in situ keratomileusis

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.

riboflavin ophthalmic solution, 0% dextran

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

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

Laser-assisted in situ keratomileusis

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Hide Arm/Group 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.

riboflavin ophthalmic solution, 0% dextran

UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)

Laser-assisted in situ keratomileusis

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.

riboflavin ophthalmic solution, 0% dextran

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

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

Laser-assisted in situ keratomileusis

All-Cause Mortality
LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/2 (0.00%)      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LASIK Followed by Cross-linking (Continuous Wave) LASIK Followed by Cross-linking (Pulsed) LASIK Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      2/2 (100.00%)      2/2 (100.00%)    
Eye disorders       
Vision blurred *  0/0  0 1/2 (50.00%)  2 1/2 (50.00%)  1
Foreign body sensation in eye *  0/0  0 1/2 (50.00%)  1 1/2 (50.00%)  1
Photophobia *  0/0  0 1/2 (50.00%)  1 1/2 (50.00%)  1
Conjunctival hyperaemia *  0/0  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Dry eye *  0/0  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Eye irritation *  0/0  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Injury, poisoning and procedural complications       
Corneal flap complication *  0/0  0 1/2 (50.00%)  1 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Site has the right to publish or communicate study results upon the earlier of: (a) publication of a multi-center publication of the Study results coordinated by Sponsor; or (b) submission of the Study data by Sponsor to the FDA; provided that the Sponsor reviews the proposed communication of results within ninety (90) days in advance of its release. Sponsor can request delay of publication or data release to allow for filing of patent application prior to the publication or release.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vineeta Belanger, VP of Clinical Affairs
Organization: Avedro, Inc.
Phone: 781-768-3459
EMail: vbelanger@avedro.com
Layout table for additonal information
Responsible Party: Avedro, Inc.
ClinicalTrials.gov Identifier: NCT01893359    
Other Study ID Numbers: KXL-004
First Submitted: June 28, 2013
First Posted: July 9, 2013
Results First Submitted: July 18, 2016
Results First Posted: October 24, 2016
Last Update Posted: June 15, 2018