Trial Outcomes & Findings for Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism (NCT NCT01893359)

Last Updated: 2021-04-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

one week to six months

Results posted on

2021-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	LASIK Followed by Cross-linking (Continuous Wave) 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	LASIK Followed by Cross-linking (Pulsed) 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	LASIK Only Eyes assigned to this arm will receive standard LASIK with no cross-linking. Laser-assisted in situ keratomileusis
Overall Study STARTED	0	2	0
Overall Study COMPLETED	0	2	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LASIK Followed by Cross-linking (Continuous Wave) 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	LASIK Followed by Cross-linking (Pulsed) n=2 Participants 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	LASIK Only Eyes assigned to this arm will receive standard LASIK with no cross-linking. Laser-assisted in situ keratomileusis	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	2 Participants n=7 Participants	—	2 Participants n=4 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Sex: Female, Male Female	—	1 Participants n=7 Participants	—	1 Participants n=4 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	—	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) White	—	2 Participants n=7 Participants	—	2 Participants n=4 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: one week to six months

Population: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: one week to twelve months

Population: This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.

Outcome measures

Outcome data not reported

Adverse Events

LASIK Followed by Cross-linking (Continuous Wave)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LASIK Followed by Cross-linking (Pulsed)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

LASIK Only

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LASIK Followed by Cross-linking (Continuous Wave) 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	LASIK Followed by Cross-linking (Pulsed) n=2 participants at risk 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	LASIK Only n=2 participants at risk Eyes assigned to this arm will receive standard LASIK with no cross-linking. Laser-assisted in situ keratomileusis
Eye disorders Vision blurred	— 0/0	50.0% 1/2 • Number of events 2	50.0% 1/2 • Number of events 1
Eye disorders Foreign body sensation in eye	— 0/0	50.0% 1/2 • Number of events 1	50.0% 1/2 • Number of events 1
Eye disorders Photophobia	— 0/0	50.0% 1/2 • Number of events 1	50.0% 1/2 • Number of events 1
Eye disorders Conjunctival hyperaemia	— 0/0	0.00% 0/2	50.0% 1/2 • Number of events 1
Eye disorders Dry eye	— 0/0	0.00% 0/2	50.0% 1/2 • Number of events 1
Eye disorders Eye irritation	— 0/0	50.0% 1/2 • Number of events 1	0.00% 0/2
Injury, poisoning and procedural complications Corneal flap complication	— 0/0	50.0% 1/2 • Number of events 1	50.0% 1/2 • Number of events 1

Additional Information

Vineeta Belanger, VP of Clinical Affairs

Avedro, Inc.

Phone: 781-768-3459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER