Fuchs' Endothelial DystrophyPhase 4NCT00781027
Fuchs' Torsional Phaco Study
A Phase 4 study testing Phacoemulsification in people with Fuchs' Endothelial Dystrophy and Phacoemulsification, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Phacoemulsification
- What is being tested?
- Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
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.
- Conditions
- Fuchs' Endothelial Dystrophy, Phacoemulsification
- Being tested
- Phacoemulsification
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemulsificationProcedure or surgery
Comparison of longitudinal phacoemulsification and torsional phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Torsional phacoemulsification Receives: Procedure: Phacoemulsification |
| 2 | Active comparator | Longitudinal phacoemulsification Receives: Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central corneal thickness/corneal volume
Measured: 1, 7 days and 1 , 3 and 6 months postoperatively
Secondary outcomes (1)
Changes in BCVA
Measured: 1, 7 days and 1, 3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Rudy MMA Nuijts, MD, PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781027
- Sponsor's protocol ID
- MEC 08-2-081
- Other IDs
- NL24769.068.08
- Status last verified
- May 2010
- First submitted
- 27 Oct 2008
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
- ClinicalTrials.gov ID
- NCT00781027
- Acronym / sponsor ID
- MEC 08-2-081
- Conditions
- Fuchs' Endothelial Dystrophy, Phacoemulsification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: PhacoemulsificationTorsional phacoemulsification |
| 2 | Active comparator | Procedure: PhacoemulsificationLongitudinal phacoemulsification |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhacoemulsificationComparison of longitudinal phacoemulsification and torsional phacoemulsification | Procedure or surgery | 1, 2 |
Primary outcome
Change in central corneal thickness/corneal volume
Time frame: 1, 7 days and 1 , 3 and 6 months postoperatively
1 secondary outcome
Changes in BCVA
Time frame: 1, 7 days and 1, 3 and 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2010.
- Derived from this study: PubMed 24030086Doors 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.
Related trials for Fuchs' Endothelial Dystrophy
RecruitingPhase 2
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
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Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudy MMA Nuijts, MD, PhD study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phacoemulsification in people with Fuchs' Endothelial Dystrophy and Phacoemulsification, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central corneal thickness/corneal volume (time frame: 1, 7 days and 1 , 3 and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2010.