Research with human participants

Overview of medical research in the Netherlands

Microinterventional endocapsular nuclear fragmentation assisted cataract surgery versus conventional phacoemulsification using divide-and-conquer: a randomized controlled trial

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Last updated:

To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Ocular structural change, deposit and degeneration NEC
Study type
Interventional

ID

NL-OMON53956

Source

ToetsingOnline

Brief title

miLOOP trial

Condition

  • Ocular structural change, deposit and degeneration NEC

Synonym

cataract, hard nucleus

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
SWOO

Intervention

Keyword :
cataract, cumulative dispersed energy, endothelial cell loss, hard nucleus

Outcome measures

Primary outcome

Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.

Secondary outcome

Procedural time, adverse events, visual acuity.

Background summary

In cataract surgery, fragmentation of a hard nucleus requires relatively much
ultrasound energy. It is suspected that the level of energy used is associated
with the degree of corneal endothelial loss. Recently, it was demonstrated that
with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy
can be substantially reduced.

Study objective

To compare miLOOP assisted cataract surgery and conventional surgery with
respect to the energy needed for phacoemulsification and loss of corneal
endothelial cells.

Study design

Randomized, controlled trial.

Intervention

Microinterventional endocapsular nuclear fragmentation.

Study burden and risks

Associated risks of participating are considered to be limited. Extra burden
involves one extra visit (3 months postoperatively), and 60 minutes of extra
time for study assessments (30+30 minutes).

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
Rotterdam 3011 BH
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Age >= 18 years. Best corrected visual acuity < 0.2 (Snellen). Advanced
visually significant nuclear sclerosis grade >= 5 (LOCS III).

Exclusion criteria

Endothelial cell density (ECD) < 1500 mm-2. Corneal opacification (any
cause). Corneal surgery or trauma.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
80
Type :
Actual

Medical products/devices used

Generic name :
miLOOP lens fragmentation device
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL83139.078.22