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

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ClinicalTrials.gov Identifier: NCT03398109
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03398109


Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS
Investigators
Study Director: Domenico Schiano-Lomoriello, MD Fondazione G.B. Bietti

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mario Stirpe, Director Clinical Research, Fondazione G.B. Bietti, IRCCS
ClinicalTrials.gov Identifier: NCT03398109     History of Changes
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors