Effectiveness of Toric Intraocular Lenses for Treating Co... | NCT03398109

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jun 29, 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jan 7, 2018

First Submission Date that Met QC Criteria

Jan 7, 2018

First Posted Date

Jan 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2018

Last Update Posted Date

Jan 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mario Stirpe, Director Clinical Research, Fondazione G.B. Bietti, IRCCSPrincipal Investigator

Lead Sponsor

Fondazione G.B. Bietti, IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Customized toric IOL	Experimental	Customized toric IOL for post-Dalk atigmatism in cataract patients	Device: Customized toric IOL for post-DALK atigmatism

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Customized toric IOL for post-DALK atigmatism	Device		Customized toric IOL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure postoperative refractive astigmatism	Postoperative refractive astigmatism expressed in diopters and measured with refraction examination	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Domenico Schiano-Lomoriello, MD	Fondazione G.B. Bietti	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30057802	Derived	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.