Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas

Keratoconus Clinical Trial

Official title:

Repeatability, Reliability and Reproducibility of Pentacam-derived Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Cross-linked Corneas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527708
• Other study ID #: 27/27-09-11
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: February 3, 2012
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Comitee
• Study type: Observational

Clinical Trial Summary

Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived curvature and zernike coefficients in back surface of normal, keratoconic and crosslinked corneas.

Description:

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.Three study groups were formed: 1) Normal 2) Keratoconus group (KC) included patients with progressive keratoconus and 3) Collagen-Cross-linking group (CXL) included keratoconus patients that had been treated with uneventful CXL at least on year prior to their enrollment in the study.

Three consecutive scans were obtained by two experienced operators. The same procedure was repeated within two weeks for the assessment of intersession variability. In all cases acceptable maps had at least 10.0mm of corneal coverage. Keratometry (K), asphericity (Q), best-fit toric ellipsoid radius (Rs), eccentricity (ecc) and aberrometry (6.0mm pupil diameter), were analyzed. Furthermore we calculated and studied CRMS and CLRMS in order to better appreciate the visual significance of HOAs. Precision (Pre), repeatability (COR) and intraclass correlation coefficient (ICC), were calculated for evaluating intrasession and intersession repeatability. Bland-Altman analysis was used for assessing interobserver repeatability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ideal refractive surgery candidate (Normal Group)

• Progressive keratoconus (Keratoconus group)

• Corneal collagen cross linking (CxL) treatment at least one year prior to enrollment (CxL group)

Exclusion Criteria:

(Normal Group)

• No indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography

• Uneventful ophthalmologic history

All groups:

• Glaucoma

• Suspicion of glaucoma

• history of herpetic keratitis

• corneal scarring

• severe eye dryness

• pregnancy or nursing

• current corneal infection

• underlying autoimmune disease

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Corneal Collagen Cross-linking (CXL)
Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 20-30 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. In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2.The UVA radiation source that was used is the UV-XTM (IROC AG, Zurich, Switzerland). Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well.

Locations

Country	Name	City	State
Greece	Eye Institute of Thrace (EIT)	Alexandroupolis	Thrace

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of posterior corneal surface curvature and aberrometric measurements within and between sessions and within and between observers.	The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study. Three consecutive scans were obtained by two experienced operators for the assessment of intrasession and interobserver variability. The same procedure was repeated within two weeks for the assessment of intersession variability.Bland-Altman plots were used to evaluate agreement between the 2 operators. The reliability of all measurements was evaluated by means of the intraclass correlation coefficient(ICC).	2 weeks	No