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Clinical Trials/NCT03398109
NCT03398109
Completed
Not Applicable

Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study

Fondazione G.B. Bietti, IRCCS0 sites10 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Astigmatism in Cataract Patients and Previous DALK
Sponsor
Fondazione G.B. Bietti, IRCCS
Enrollment
10
Primary Endpoint
Measure postoperative refractive astigmatism
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

the purpose of this study was to assess the efficacy of custom made toric intraocular lens implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.

Detailed Description

Patients undergoing cataract surgery after DALK for keratoconus were enrolled. Total corneal astigmatism (TCA)was assessed by a rotating Scheimpflug camera combined with Placido disk corneal topography (Sirius; CSO, Firenze, Italy). A customized toric IOL (FIL 611 T, Soleko) was implanted in all eyes. One year postoperatively, refraction was measured, the IOL position was recorded, and vectorial and non-vectorial analysis were performed to evaluate the correction of astigmatism.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fondazione G.B. Bietti, IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Mario Stirpe

Director Clinical Research

Fondazione G.B. Bietti, IRCCS

Eligibility Criteria

Inclusion Criteria

  • Corneal suture removal had been performed in all cases at least 1 year before cataract surgery.
  • Corneal astigmatism was stable at least since 6 months before the cataract surgery

Exclusion Criteria

  • other ocular pathologies as glaucoma, retinal disease.

Outcomes

Primary Outcomes

Measure postoperative refractive astigmatism

Time Frame: 6 months

Postoperative refractive astigmatism expressed in diopters and measured with refraction examination

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