Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus

NCT01527721 | Completed

• 1 other identifier: 3/2/2012 37
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of this study was to assess the impact of the two prevalent therapeutic options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on both anterior and posterior corneal High order aberations (HOAs).

Conditions

Keratoconus

Keywords

keratoconus; CxL; CxL combined with t-PRK

Outcome Measures

Primary Outcomes (1)

• Higher order corneal aberations

  1 year postoperatively

Study Arms (2)

CxL group

EXPERIMENTAL

Volunteers of this group received CxL treatment.

Procedure: Corneal Collagen Cross-Linking (CxL)

tCxL group

EXPERIMENTAL

Volunteers of this group received CxL combined with t-PRK treatment

Procedure: Corneal Collagen Cross-Linking combined with t-PRK

Interventions

Corneal Collagen Cross-Linking (CxL) PROCEDURE

The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The UVA radiation source was UV-XTM Zurich, . Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.

CxL group

Corneal Collagen Cross-Linking combined with t-PRK PROCEDURE

For tCxL group, the topo-guided PRK preceded the CXL. The epithelium was mechanically removed with a hockey knife and ablation was performed in a 9.0 mm zone with a maximal intended ablation depth of 50μm. No adjuvant Mitomycin-C was applied in any case. For the photorefractive ablation we used the Allegretto Wave 200 Hz (1.0071-1-0.81/1.208 software/ WaveLight AG, Erlangen, Germany) with the T-CAT ablation profile.

tCxL group

Eligibility Criteria

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

You may qualify if:

• progressive keratoconus

You may not qualify if:

• glaucoma or suspicion for glaucoma,
• central corneal thickness (CCT) less than 400μm,
• K-readings more than 60D,
• history of herpetic keratitis,
• pregnancy or nursing,
• underlying autoimmune disease

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Eye Institute of Thrace (EIT)

Alexandroupoli, Greece

Location

Related Publications (1)

• Labiris G, Sideroudi H, Angelonias D, Georgantzoglou K, Kozobolis VP. Impact of corneal cross-linking combined with photorefractive keratectomy on blurring strength. Clin Ophthalmol. 2016 Apr 1;10:571-6. doi: 10.2147/OPTH.S100770. eCollection 2016.

  PMID: 27099464 RESULT

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer of Ophthalmology

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

GR (1)