Aqualase Versus Torsional ip. A Study on Endothelial Cell... | NCT01480557

Studies
Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

NCT01480557

Sponsor

Democritus University of Thrace

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

liquefaction
Torsional ip

Countries

Greece

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

Jan 2017

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

Apr 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 22, 2011

First Submission Date that Met QC Criteria

Nov 28, 2011

First Posted Date

Nov 29, 2011Estimated

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 14, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georgios Labiris, Senior Lecturer, 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

Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.

Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).

Detailed Description

Not provided

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

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liquefaction group	Active Comparator	Subjects that were operated for cataract using liquefaction technology	Procedure: liquefaction
Torsional ip group	Active Comparator	Subjects that were operated for cataract using torsional ip technology	Procedure: Torsional ip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liquefaction	Procedure	Cataract extraction surgery type	Liquefaction group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endothelial cell count (ECC)		1 month postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Uncorrected visual acuity (UVA)		1 month postoperatively
Central corneal thickness (CCT)		1 month postoperatively
Central Corneal Sensitivity (CCS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of senile cataract with stage 2 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

55 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios Labiris, MD, PhD	Democritus University of Thrace	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Alexandroupolis		Alexandroupoli	Evros	68100	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23095606	Result	Labiris G, Gatzioufas Z, Giarmoukakis A, Sideroudi H, Kozobolis VP. Liquefaction versus torsional IP: a comparative study on endothelial cells, corneal edema and corneal sensitivity. Ophthalmic Res. 2013;49(1):37-42. doi: 10.1159/000342974. Epub 2012 Oct 23.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases