Fuchs' Torsional Phaco Study | NCT00781027

Studies
Fuchs' Torsional Phaco Study

NCT00781027

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

May 20, 2010Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Fuchs' Endothelial Dystrophy
Phacoemulsification

Interventions

Phacoemulsification

Countries

Netherlands

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

ID	Type	Description	Link
NL24769.068.08

Status Module

Record Verification Date

May 2010

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

Dec 2008

Primary Completion Date

May 2010Actual

Completion Date

Not provided

First Submitted Date

Oct 27, 2008

First Submission Date that Met QC Criteria

Oct 27, 2008

First Posted Date

Oct 28, 2008Estimated

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

May 19, 2010

Last Update Posted Date

May 20, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Maastricht University Medical CenterOTHER

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

The primary objective is to compare the effect of torsional phacoemulsification and longitudinal phacoemulsification on central and peripheral corneal thickness/volume after cataract surgery in patients with Fuchs' endothelial dystrophy.

Detailed Description

Fuchs' endothelial dystrophy is a progressive, bilateral disease of the corneal endothelium, which eventually leads to corneal decompensation. In the early stage, some patients develop visually significant cataract. During cataract surgery ultrasound (US) power is used to emulsify the lens, which leads to endothelial cell loss and tissue damage. The reduction of US power has become the primary surgical goal in cataract surgery, which is especially important in patients with Fuchs' endothelial dystrophy to limit endothelial cell loss.

In 2006, Alcon Surgical introduced a torsional mode in its phacoemulsification system (Infiniti Vision System). It includes a handpiece that produces rotary oscillations of the phacoemulsification tip and is suggested to reduce the amount of US power required to remove the cataractous nucleus, because it does not produce repulsion and breaks up the cataract by shearing and not by the conventional jackhammer effect. This reduction in US power, could lead to less endothelial cell damage than the conventional (longitudinal) mode, which is reported recently for patients with hard cataract. It is important to investigate patients with Fuchs' endothelial dystrophy, because patients with a compromised endothelial cell layer will benefit the most from less endothelial cell damage. Consequently, this lower level of endothelial damage may postpone the date of keratoplasty.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Torsional phacoemulsification	Procedure: Phacoemulsification
2	Active Comparator	Longitudinal phacoemulsification	Procedure: Phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phacoemulsification	Procedure	Comparison of longitudinal phacoemulsification and torsional phacoemulsification	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in central corneal thickness/corneal volume		1, 7 days and 1 , 3 and 6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Changes in BCVA		1, 7 days and 1, 3 and 6 months postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Fuchs' endothelial dystrophy (all stages) and planning to undergo cataract surgery due to visually significant cataract
Patients should be 40 years of age or older

Exclusion Criteria:

Patients with Fuchs' dystrophy with a history of previous corneal or intraocular surgery
Patients with a planned combined surgical procedure
Patients who have other vision-affecting disorders than Fuchs' endothelial dystrophy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
Rudy MMA Nuijts, MD, PhD	Maastricht University Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Maastricht		Maastricht		6202 AZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24030086	Derived	Doors M, Berendschot TT, Touwslager W, Webers CA, Nuijts RM. Phacopower modulation and the risk for postoperative corneal decompensation: a randomized clinical trial. JAMA Ophthalmol. 2013 Nov;131(11):1443-50. doi: 10.1001/jamaophthalmol.2013.5009.

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary

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