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Outcome Measures

Primary Outcomes (2)

Change from baseline in uncorrected visual acuity
Change from baseline in distance uncorrected visual acuity
1, 3, 6 and 12 months after treatment
Change from baseline in spherical equivalent
Change from baseline in spherical equivalent on subjective distance refraction
1, 3, 6 and 12 months after treatment

Secondary Outcomes (1)

Change from baseline in corneal endothelial cell density
12 months after treatment

Study Arms (2)

PiXL Protocol A

EXPERIMENTAL

PiXL treatment with UV irradiation in a central 4 mm homogenous zone of the cornea. For myopia of less than 1.0D, 10 J/cm2 will be used, for higher levels of myopia 15J/cm2 will be used.

Procedure: PiXL

PiXL Protocol B

ACTIVE COMPARATOR

PiXL treatment with UV irradiation in a central ring-shaped 4-mm area of the cornea. A central 2-mm zone is left untreated, and the energy is higher towards the periphery of the ring-shaped area, reaching its maximum at 2 mm from the corneal centre. For myopia of less than 1.0D, a maximum of 10 J/cm2 will be used, for higher levels of myopia a maximum of 15J/cm2 will be used.

Procedure: PiXL

Interventions

PiXLProcedure

Phototherapeutic intrastromal corneal collagen cross-linking (PiXL) performed in a high-oxygen environment without corneal epithelial debridement, for treatment of mild myopia.

PiXL Protocol APiXL Protocol B

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Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

PARTICIPANT

Masking Details

The participants are not aware which eye will receive the homogeneous zone treatment and which eye will receive the ring-shaped treatment.

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: Prospective, single-masked intraindividually comparing randomized controlled trial. Participants will be randomized to receive ultraviolet (UV) light according to protocol A in one eye and protocol B in the other, which is masked to the participant. Both eyes will be treated during the same visit. Protocol A: UV irradiation in a central 4 mm homogenous zone of the cornea. Protocol B: UV irradiation in a central ring-shaped 4 mm area of the cornea. Patients are randomized utilizing a computer list of unique random numbers between 1 and 23; an even number will be treated with a homogeneous zone in the right eye; an uneven number with a homogeneous zone in the left eye.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Advanced Cross Linking for Low-grade Myopia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

PiXL Protocol A

PiXL Protocol B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (2)

PiXL Protocol A

PiXL Protocol B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations