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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01527721
Other study ID # 3/2/2012 37
Secondary ID
Status Completed
Phase N/A
First received February 3, 2012
Last updated January 14, 2017
Start date September 2010
Est. completion date January 2012

Study information

Verified date January 2017
Source Democritus University of Thrace
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.32 patients with keratoconus were included in the study. Of them, 19 patients underwent CxL treatment (CxL group), while the rest 13 patients underwent CxL combined with t-PRK (tCxL) [tCxL group]. If both eyes were eligible, only one eye was enrolled in the study.Regarding Scheimpflug camera (Pentacam Classic, Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04 ) measurements, acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded.

For both anterior and posterior corneal surfaces, Pentacam-derived HOAs parameters for both pupil diameters of 4mm and 6mm were calculated, as well as the HOA root mean square (RMS)values. Pentacam-derived HOA measurements were obtained one day prior to treatment and then one year post-op.The impact of the surgical technique (either CXL or tCXL) on spherocylindrical error was evaluated by power vector analysis as described before. Furthermore, manifest refractions comprising of sphere (S), cylinder (C) and axis (φ), were converted into three dioptric powers (M, J0 and J45). Moreover, we calculated the overall blurring strength (B) of the spherocylindrical error by measuring the length of the produced vector.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- progressive keratoconus

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Corneal Collagen Cross-Linking (CxL)
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.
Corneal Collagen Cross-Linking combined with t-PRK
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Higher order corneal aberations 1 year postoperatively
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