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Clinical Trials/NCT03398109
NCT03398109CompletedNot 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 enrollmentStarted: May 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Primary Endpoint
Measure postoperative refractive astigmatism

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to 80 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Mario Stirpe

Director Clinical Research

Fondazione G.B. Bietti, IRCCS

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