Glistenings and PCO Evaluation for the Envista MX60 | NCT02698943

Studies
Glistenings and PCO Evaluation for the Envista MX60

NCT02698943

Sponsor

Democritus University of Thrace

Status

Completed

Last Update Posted

Mar 4, 2016Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Cataract

Interventions

Phacoemulsification

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

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

Sep 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Mar 2, 2016

First Submission Date that Met QC Criteria

Mar 2, 2016

First Posted Date

Mar 4, 2016Estimated

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

Mar 2, 2016

Last Update Posted Date

Mar 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Labiris, Assistant Professor, Democritus University of ThracePrincipal Investigator

Lead Sponsor

Democritus University of ThraceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Posterior capsule opacification (PCO) and glistenings development is among the primary reasons for sub-optimal visual capacity following cataract extraction surgery. Primary objective of this study is to evaluate the incidence of PCO and glistenings of the popular envista MX-60 intraocular lens (Bausch + Lomb) in a random sample of cataract patients who underwent phacoemulsification at least 1 year prior to their enrollment at the study

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Participants who underwent phacoemulsification surgery and implantation of the Envista MX-60 IOL	Procedure: Phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phacoemulsification	Procedure	Phacoemulsification for cataract extraction with Envista MX-60 implantation	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glistenings	Evaluation of glistenings using Scheimpflug analysis	1 year
Posterior capsule Opacification (PCO)	Evaluation of PCO using EPCO software	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

Endothelial cell count less than 1900, glaucoma, IOP-lowering medications, former incisional surgery, former diagnosis of corneal disease, diabetes or autoimmune diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Participants with senile cataract

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Georgios Labiris, MD, PhD	Assistant Professor	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided