Advanced Cross Linking for Low-grade Myopia

NCT03197272 | Completed

• 1 other identifier: PiXLMYOP-I
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the improvement in myopic refractive error and the corneal endothelial safety with a corneal crosslinking treatment regimen for mild myopia. The treatment involves a 4-mm central treatment zone in high oxygen environment without corneal epithelial debridement.

Conditions

Myopia; Corneal Crosslinking

Keywords

Myopia; corneal Crosslinking

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

PiXL PROCEDURE

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

PiXL Protocol A; PiXL Protocol B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Spherical equivalent on distance subjective refraction between -0.50D and -2.50D.
• Astigmatism ≤ 0.75D
• Stable myopia. Maximum change in refraction of 0.50D in the last 2 years.
• Best corrected visual acuity of at least 0.00 logMAR (ETDRS chart).
• Thinnest pachymetry reading ≥ 440 μm.
• No previous ocular surgery.
• No cognitive insufficiency interfering with the informed consent.

You may not qualify if:

• History of or current ocular condition, disease, surgery or medication with ocular effects that could affect the outcomes of the treatment.
• Allergy to any substance or device used in the study.
• Cognitive insufficiency interfering with the informed consent.

Sponsors & Collaborators

• Umeå University: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Department of Clinical Sciences/Ophthalmology, Umeå University

Umeå, 901 85, Sweden

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Anders Behndig, MD, PhD

  Department of Clinical Sciences/Ophthalmology, Umeå University, Umeå, Sweden

  PRINCIPAL INVESTIGATOR

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: April 21, 2016
• Primary Completion: October 31, 2020
• Study Completion: November 30, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)