Parameters of 2 Phaco Tips Designs in Torsional Phacoemul... | NCT02089698

Studies
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification

NCT02089698

Sponsor

Hospital Oftalmologico de Brasilia

Status

Completed

Last Update Posted

Mar 18, 2014Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Cataract

Interventions

Mini-flared
Reversed tip

Countries

Brazil

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 2014

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 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 12, 2014

First Submission Date that Met QC Criteria

Mar 15, 2014

First Posted Date

Mar 18, 2014Estimated

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 15, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PATRICK FRENSEL DE MORAES TZELIKIS, Principal Investigator, Hospital Oftalmologico de BrasiliaPrincipal Investigator

Lead Sponsor

Hospital Oftalmologico de BrasiliaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.

Detailed Description

In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).

The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reversed tip	Active Comparator	Reversed Kelman tip	Device: Mini-flared
Mini-flared	Experimental	Mini-flared Kelman tip	Device: Reversed tip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mini-flared	Device	Mini-flared Kelman tip	Reversed tip
Reversed tip

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities		90 days

Secondary Outcomes

Measure	Description	Time Frame
Phaco time used		1 day, 90 days

Other Outcomes

Measure	Description	Time Frame
Cumulative dissipated energy (CDE) required		1 day, 90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

Exclusion Criteria:

Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 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
Patrick F Tzelikis, MD, PhD	Hospital Oftalmologico de Brasilia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Oftalmologico de Brasília		Brasília	Federal District	70000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15030845	Result	Vargas LG, Holzer MP, Solomon KD, Sandoval HP, Auffarth GU, Apple DJ. Endothelial cell integrity after phacoemulsification with 2 different handpieces. J Cataract Refract Surg. 2004 Feb;30(2):478-82. doi: 10.1016/S0886-3350(03)00620-5.
16863978	Result	Payne M, Georgescu D, Waite AN, Olson RJ. Phacoemulsification tip vacuum pressure: Comparison of 4 devices. J Cataract Refract Surg. 2006 Aug;32(8):1374-7. doi: 10.1016/j.jcrs.2006.02.066.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases