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Outcome Measures

Primary Outcomes (1)

Maximal keratometry (Kmax)
Kmax assessed with the Pentacam HR Scheimpflug camera, Diopters.
1 month, 3 months, 6 months, 12 months and 24 months after treatment

Secondary Outcomes (10)

Uncorrected distance visual acuity (UDVA)
1 month, 3 months, 6 months, 12 months and 24 months after treatment
Best corrected visual acuity (BCVA)
1 month, 3 months, 6 months, 12 months and 24 months after treatment

Interventions

Epi-on PiXLProcedure

Photorefractive intrastromal crosslinking (PiXL) After local anaesthetics, the cornea is soaked in Riboflavin by repeated topical application during 10 minutes. For masking purposes, epithelial debridement is simulated by moving a scraping instrument in front of the cornea. A Riboflavin soaked sponge is used to lightly disrupt the epithelium tight junctions, without epithelium debridement. The cornea is illuminated with PiXL under 16:40 minutes during continuously delivery of humidified high oxygen via specific oxygen goggles. The UV-dosage is individually customized based upon Kmax; \< 45D, 7.2J/cm2; 45-50D, 10J/cm2; \> 50D, 15 J/cm2.

Epi-on PiXL

Epi-Off PiXLProcedure

Eligibility Criteria

Age18 Years - 35 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Patients planned for corneal crosslinking.
Progressive keratoconus documented with a consistent decrease of best corrected visual acuity with no other explanation, an unquestionable historical progression, or a progression documented with the Pentacam Scheimpflug camera with at least 2 of the following: progressive anterior and/or posterior corneal steepening and/or progressive corneal thinning and/or increased rate of corneal thickness change from the periphery to the center.

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 Epi-off PiXL treatment and which eye will receive the Epi-on PiXL treatment.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Prospective, single-masked intraindividually comparing randomized controlled trial. Participants will be randomized to receive Epi-off PiXL in one eye and Epi-on PiXL in the other, which is masked to the participant. The participant can choose to treat in eye at a time or both eyes during the same visit.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

Photorefractive Intrastromal Crosslinking (PiXL) for the Treatment of Progressive Keratoconus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Epi-on PiXL

Epi-off PiXL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

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

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Epi-on PiXL

Epi-off PiXL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations