Variability of Pentacam-derived Back Elevation Measurements in Keratoconus and Cross-linked Corneas

NCT ID: NCT01471873

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-11-30

Brief Summary

Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived posterior corneal elevation measurements in keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment due to progressive keratoconus.

Detailed Description

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.Two study groups were formed: 1) Keratoconus group (KC) included patients with progressive keratoconus and 2) 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.All back elevation points were codified in order to facilitate statistical processing of data. Further to single point analysis, three additional parameters were evaluated: a) zone 4 parameter (z4) which derived by the analysis of all points at the central 4.0mm diameter zone, b) zone 8 parameter (z8) which derived by the analysis of all points at the central 8.0mm diameter zone, and, c) highest elevation point parameter (HEP), which derived by the analysis of the highest elevation points for all participants. Reproducibility of measurements was evaluated by means of intraclass correlation coefficients (ICC). Three different ICC types were calculated: a) intrasession ICC for both operators (ICC1 & ICC2), b) interobserver ICC, and, c) intersession ICC. Moreover, Bland-Altman plots were used to evaluate the level of agreement between the two operators.

Conditions

Keratoconus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Keratoconus Group (KG)

Keratoconus group (KG) included patients with progressive keratoconus.

No interventions assigned to this group

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.

Corneal Collagen Cross-linking (CXL)

Intervention Type: PROCEDURE

The same surgical procedure was applied to all CXLG 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 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.

Interventions

Corneal Collagen Cross-linking (CXL)

The same surgical procedure was applied to all CXLG 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 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Glaucoma
• Suspicion of glaucoma
• history of herpetic keratitis
• corneal scarring
• severe eye dryness
• pregnancy or nursing
• current corneal infection
• underlying autoimmune disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Democritus University of Thrace

OTHER

Sponsor Role: lead

Responsible Party

Georgios Labiris

Senior Lecturer of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Institute of Thrace (EIT)

Alexandroupoli, Thrace, Greece

Countries

Greece

References

Labiris G, Giarmoukakis A, Sideroudi H, Bougatsou P, Lazaridis I, Kozobolis VP. Variability in Scheimpflug image-derived posterior elevation measurements in keratoconus and collagen-crosslinked corneas. J Cataract Refract Surg. 2012 Sep;38(9):1616-25. doi: 10.1016/j.jcrs.2012.04.039.

Reference Type: RESULT

PMID: 22906447 (View on PubMed)

Other Identifiers

25/27-09-2011

Identifier Type: -

Identifier Source: org_study_id