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

NCT ID: NCT03398109

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Corneal Astigmatism in Cataract Patients and Previous DALK

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Customized toric IOL

Customized toric IOL for post-Dalk atigmatism in cataract patients

Group Type EXPERIMENTAL

Customized toric IOL for post-DALK atigmatism

Intervention Type DEVICE

Interventions

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Customized toric IOL for post-DALK atigmatism

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione G.B. Bietti, IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Mario Stirpe

Director Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Domenico Schiano-Lomoriello, MD

Role: STUDY_DIRECTOR

Fondazione G.B. Bietti

References

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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.

Reference Type DERIVED
PMID: 30057802 (View on PubMed)

Other Identifiers

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N. 24/15/FB

Identifier Type: -

Identifier Source: org_study_id

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