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Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03398109
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Mario Stirpe, Fondazione G.B. Bietti, IRCCS

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.

Condition or disease Intervention/treatment Phase
Corneal Astigmatism in Cataract Patients and Previous DALK Device: Customized toric IOL for post-DALK atigmatism Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Customized toric IOL
Customized toric IOL for post-Dalk atigmatism in cataract patients
Device: Customized toric IOL for post-DALK atigmatism

Primary Outcome Measures :
  1. Measure postoperative refractive astigmatism [ Time Frame: 6 months ]
    Postoperative refractive astigmatism expressed in diopters and measured with refraction examination

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03398109

Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS
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Study Director: Domenico Schiano-Lomoriello, MD Fondazione G.B. Bietti
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mario Stirpe, Director Clinical Research, Fondazione G.B. Bietti, IRCCS Identifier: NCT03398109    
Other Study ID Numbers: N. 24/15/FB
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Refractive Errors