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

Primary Purpose

Corneal Astigmatism in Cataract Patients and Previous DALK

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Customized toric IOL for post-DALK atigmatism
Sponsored by
Fondazione G.B. Bietti, IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Astigmatism in Cataract Patients and Previous DALK

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Customized toric IOL

    Arm Description

    Customized toric IOL for post-Dalk atigmatism in cataract patients

    Outcomes

    Primary Outcome Measures

    Measure postoperative refractive astigmatism
    Postoperative refractive astigmatism expressed in diopters and measured with refraction examination

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2018
    Last Updated
    January 7, 2018
    Sponsor
    Fondazione G.B. Bietti, IRCCS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03398109
    Brief Title
    Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK
    Official Title
    Customized Toric Intraocular Lens Implantation in Eyes With Cataract and Corneal Astigmatism After Deep Anterior Lamellar Keratoplasty (DALK): a Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (Actual)
    Primary Completion Date
    June 29, 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione G.B. Bietti, IRCCS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Astigmatism in Cataract Patients and Previous DALK

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Customized toric IOL
    Arm Type
    Experimental
    Arm Description
    Customized toric IOL for post-Dalk atigmatism in cataract patients
    Intervention Type
    Device
    Intervention Name(s)
    Customized toric IOL for post-DALK atigmatism
    Primary Outcome Measure Information:
    Title
    Measure postoperative refractive astigmatism
    Description
    Postoperative refractive astigmatism expressed in diopters and measured with refraction examination
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Domenico Schiano-Lomoriello, MD
    Organizational Affiliation
    Fondazione G.B. Bietti
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30057802
    Citation
    Schiano Lomoriello D, Savini G, Naeser K, Colabelli-Gisoldi RM, Bono V, Pocobelli A. Customized Toric Intraocular Lens Implantation in Eyes with Cataract and Corneal Astigmatism after Deep Anterior Lamellar Keratoplasty: A Prospective Study. J Ophthalmol. 2018 Jul 3;2018:1649576. doi: 10.1155/2018/1649576. eCollection 2018.
    Results Reference
    derived

    Learn more about this trial

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

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