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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT01527708
First received: February 3, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Keratoconus
Procedure: Corneal Collagen Cross-linking (CXL)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Repeatability, Reliability and Reproducibility of Pentacam-derived Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Cross-linked Corneas

Resource links provided by NLM:


Further study details as provided by Democritus University of Thrace:

Primary Outcome Measures:
  • Variability of posterior corneal surface curvature and aberrometric measurements within and between sessions and within and between observers. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 129
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Keratoconus Group (KCG)
Keratoconus group (KCG) included patients with progressive keratoconus.
Collagen-Cross-linking group (CXLG)
Collagen-Cross-linking group (CXLG) included keratoconus patients that had been treated with uneventful corneal collagen cross-linking (CXL) at least on year prior to their enrolment in the study.
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.
Normal Group (NG)
Normal group (NG) was formed by refractive surgery candidates who visited EIT's refractive surgery service for their preoperative examination. Eligibility for participation in the NG was confirmed by consecutive topographies, while all NG participants had to present uneventful ophthalmologic history, no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants were recruited from the Cornea service of the EIT in a consecutive-if-eligible basis.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527708

Locations
Greece
Eye Institute of Thrace (EIT)
Alexandroupolis, Thrace, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
Principal Investigator: Georgios Labiris, Lecturer Democritus University of Thrace
  More Information

No publications provided

Responsible Party: Georgios Labiris, Lecturer, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT01527708     History of Changes
Other Study ID Numbers: 27/27-09-11
Study First Received: February 3, 2012
Last Updated: February 3, 2012
Health Authority: Greece: Ethics Comitee

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014