NCT03398109

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

January 7, 2018

Last Update Submit

January 7, 2018

Conditions

Corneal Astigmatism in Cataract Patients and Previous DALK

Outcome Measures

Primary Outcomes (1)

  • Measure postoperative refractive astigmatism

    Postoperative refractive astigmatism expressed in diopters and measured with refraction examination

    6 months

Study Arms (1)

Customized toric IOL

EXPERIMENTAL

Customized toric IOL for post-Dalk atigmatism in cataract patients

Device: Customized toric IOL for post-DALK atigmatism

Interventions

Customized toric IOL for post-DALK atigmatismDEVICE
Customized toric IOL

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other ocular pathologies as glaucoma, retinal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30057802DERIVED

Study Officials

  • Domenico Schiano-Lomoriello, MD

    Fondazione G.B. Bietti

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Clinical Research

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 12, 2018

Study Start

May 1, 2016

Primary Completion

June 29, 2017

Study Completion

July 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01