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CompletedNCT00781027Updated May 20, 2010

Fuchs' Torsional Phaco Study

A Phase 4 interventional study of Phacoemulsification in Fuchs' Endothelial Dystrophy and Phacoemulsification, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2010-05-20.

Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fuchs' Endothelial Dystrophy
  • Phacoemulsification
03

In context

Fuchs' Endothelial Dystrophy

90 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 28 are open to participants now.

This study's planned enrollment of 50 is close to the median of 54 across 63 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    1

    Torsional phacoemulsification

    Procedure: Phacoemulsification

  • Active comparator
    2

    Longitudinal phacoemulsification

    Procedure: Phacoemulsification

Interventions

  • ProcedurePhacoemulsification

    Comparison of longitudinal phacoemulsification and torsional phacoemulsification

06

What researchers measure

Primary outcomes

  1. Change in central corneal thickness/corneal volume

    Time frame: 1, 7 days and 1 , 3 and 6 months postoperatively

Secondary outcomes

  1. Changes in BCVA

    Time frame: 1, 7 days and 1, 3 and 6 months postoperatively

07

Study locations

1 site
  • University Hospital Maastricht
    Maastricht, 6202 AZ, Netherlands
08

References and documents

Publications

  • 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. PubMed 24030086 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00781027
Lead sponsor
Maastricht University Medical Center
First posted
Oct 28, 2008
Start date
Dec 2008
Primary completion
May 2010
Last update
May 20, 2010

Study contacts

Rudy MMA Nuijts, MD, PhD
study director · Maastricht University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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