NCT00781027

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

May 20, 2010

Status Verified

May 1, 2010

Enrollment Period

1.4 years

First QC Date

October 27, 2008

Last Update Submit

May 19, 2010

Conditions

Fuchs' Endothelial DystrophyPhacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Change in central corneal thickness/corneal volume

    1, 7 days and 1 , 3 and 6 months postoperatively

Secondary Outcomes (1)

  • Changes in BCVA

    1, 7 days and 1, 3 and 6 months postoperatively

Study Arms (2)

1

ACTIVE COMPARATOR

Torsional phacoemulsification

Procedure: Phacoemulsification

2

ACTIVE COMPARATOR

Longitudinal phacoemulsification

Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

Comparison of longitudinal phacoemulsification and torsional phacoemulsification

12

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24030086DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Rudy MMA Nuijts, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

December 1, 2008

Primary Completion

May 1, 2010

Last Updated

May 20, 2010

Record last verified: 2010-05

Locations

NL(1)