Treatment of Keratoconus With Advanced CXL-II

NCT02514200 | Unknown Phase 2

• 1 other identifier: KXL2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether individualized, topography-based corneal crosslinking for keratoconus can improve the optical outcomes of the treatment.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in refraction

  Change from baseline in refractive errors, including lower and higher order aberrations in the cornea.

  1, 3, 6 and 12 months after the treatment

Secondary Outcomes (5)

• Change from baseline in ETDRS LogMAR visual acuity

  1, 3, 6 and 12 months after the treatment

• Change from baseline in corneal densitometry

  1, 3, 6 and 12 months after the treatment

• Change from baseline in corneal biomechanical stability measured with GAT

  1, 3, 6 and 12 months after the treatment

• Change from baseline in corneal biomechanical stability measured with CorVis®

  1, 3, 6 and 12 months after the treatment

• Change from baseline in corneal endothelial morphometry

  1, 3, 6 and 12 months after the treatment

Study Arms (2)

Topography-based CXL (KXL2)

EXPERIMENTAL

Individualized pulsed topography-based corneal crosslinking; 1 second on, 1 second off; 7.2J/cm2 - 15.0J/cm2; arcuate treatment zone. The Avedro KXL II™ System is used for the crosslinking after epithelial debridement in topical anesthesia and application of topical riboflavin every 3 minutes for 10 minutes.

Procedure: Topography-based CXL (KXL2); Drug: Riboflavin; Device: Avedro KXL II

Conventional pulsed CXL (pCXL)

ACTIVE COMPARATOR

Conventional pulsed corneal crosslinking; 1 second on, 1 second off; 5.4 J/cm2; 8 mm central treatment zone. The Avedro KXL II™ System is used for the crosslinking after epithelial debridement in topical anesthesia and application of topical riboflavin every 3 minutes for 10 minutes.

Procedure: Conventional pulsed CXL (pCXL); Drug: Riboflavin; Device: Avedro KXL II

Interventions

Topography-based CXL (KXL2) PROCEDURE

The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a topography-based arcuate shape with the Avedro KXL2® with an energy from 7.2-15.0 J/cm2 depending on the severity of the keratoconus.

Topography-based CXL (KXL2)

Conventional pulsed CXL (pCXL) PROCEDURE

The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a central round 8mm zone with the Avedro KXL2® with an energy of 5.4 J/cm2.

Conventional pulsed CXL (pCXL)

Riboflavin DRUG

Riboflavin is added topically immediately before the treatment every 3 minutes during 10 minutes in the eye to be treated

Conventional pulsed CXL (pCXL); Topography-based CXL (KXL2)

Avedro KXL II DEVICE

The KXL II™ System crosslinking device from Avedro, Inc. is used for ultraviolet irradiation of the cornea after riboflavin application in both treatment arms.

Conventional pulsed CXL (pCXL); Topography-based CXL (KXL2)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for corneal crosslinking.
• Uni-or bilateral keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" keratoconus quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam HR® Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
• Progression of the keratoconus in the eye in question, documented with Scheimpflug photography using the Oculus Pentacam HR® Scheimpflug camera and/or repeated subjective refraction and keratometry.
• Minimum corneal thickness of 400 μm at the thinnest point after epithelial removal.
• ≥12 years of age
• No ocular abnormalities except keratoconus
• No previous ocular surgery
• No cognitive insufficiency interfering with the informed consent.

You may not qualify if:

• Age under 12
• Any corneal abnormalities except keratoconus
• Previous ocular surgery
• Cognitive insufficiency

Sponsors & Collaborators

• Umeå University: lead

Related Publications (1)

• Nordstrom M, Schiller M, Fredriksson A, Behndig A. Refractive improvements and safety with topography-guided corneal crosslinking for keratoconus: 1-year results. Br J Ophthalmol. 2017 Jul;101(7):920-925. doi: 10.1136/bjophthalmol-2016-309210. Epub 2016 Nov 29.

  PMID: 27899371 DERIVED

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: March 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 16, 2018

Record last verified: 2017-12