PiXL as a Treatment for Low Grade Myopia

NCT04663048 | Unknown

• 1 other identifier: PiXLMYOP-III
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the improvement in myopia with phototherapeutic intrastromal corneal collagen cross-linking (PiXL) without epithelial debridement (epi-on) in high oxygen environment for low grade myopia. The study compares two 3.5-mm central ring-shaped zone protocols; 10 min illumination time vs 16:40 min illumination time.

Conditions

Myopia; Refractive Errors

Keywords

Corneal Crosslinking

Outcome Measures

Primary Outcomes (2)

• Uncorrected distance visual acuity (UDVA)

  Change from baseline in UDVA (logMAR)

  1, 3, 6 and 12 months after treatment.

• Manifest Refractive Spherical Equivalent

  Change from baseline in MRSE (Diopters)

  1, 3, 6 and 12 months after treatment

Secondary Outcomes (3)

• Best spectacle corrected visual acuity (BSCVA)

  1, 3, 6 and 12 months after treatment

• Endothelial cell density (ECC)

  1, 3, 6 and 12 months after treatment

• Low contrast visual acuity at 10% and 2.5% (LCVA)

  1, 3, 6 and 12 months after treatment

Study Arms (2)

Protocol A

EXPERIMENTAL

PiXL treatment with pulsed UV illumination (1.0 sec on /0.8 sec off) in high oxygen in a central ring-shaped 3.5-mm zone of the cornea and total illumination time of 10 min. The area consist of three rings with a central 1.5-mm zone that is left untreated. The illumination area consists of three rings, where the outer and inner ring are thinner than the middle ring. The maximum energy is distributed in the middle ring.

Procedure: PiXL

Protocol B

ACTIVE COMPARATOR

PiXL treatment with pulsed (0.5 sec on / 1 sec off) UV illumination in high oxygen in a central ring-shaped 3.5-mm zone of the cornea and total illumination time of 16:40 min. The area consist of three rings with a central 1.5-mm zone that is left untreated. The illumination area consists of three rings, where the outer and inner ring are thinner than the middle ring. The maximum energy is distributed in the middle ring.

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 low grade myopia.

Protocol A; 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 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)

Umeå University Hospital

Umeå, 90185, Sweden

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Anders Behndig, MD, PhD

  Umeå University Hospital

  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 reduced treatment and which eye will receive the ordinary treatment time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 10, 2020
• Study Start: February 7, 2019
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)