CataractsPhase 2/3NCT00932191
Endothelial Cell Loss After Cataract Surgery
A Phase 2/3 study testing Standard phacoemulsification and Reduced ultrasound phacoemulsification in people with Cataracts, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Standard phacoemulsification and Reduced ultrasound phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2012
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visually significant moderate density cataract
Who cannot join
- Corneal or retinal pathology limiting visual potential to worse than 20/40
- Lens pathology including pseudoexfoliation or lens dislocation
- Prior intraocular surgery
- Age less than 40
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique
The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.
- Conditions
- Cataracts
- Being tested
- Standard phacoemulsification, Reduced ultrasound phacoemulsification
- Keywords
- Cataract, Corneal endothelial cell loss, Ultrasound power, Corneal endothelium
- Medical subject headings
- Cataract, Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard phacoemulsificationProcedure or surgery
Cataract nucleus removal using standard amounts of ultrasound energy
Reduced ultrasound phacoemulsificationProcedure or surgery
Cataract nucleus removal using less ultrasound energy and more mechanical energy.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound phacoemulsification | Active comparator | Cataract nucleus is removed using standard amounts of ultrasound energy. Receives: Procedure: Standard phacoemulsification |
| Reduced ultrasound phacoemulsification | Active comparator | Cataract nucleus removal using less ultrasound energy and more mechanical energy. Receives: Procedure: Reduced ultrasound phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cell loss by specular microscopy after cataract surgery
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Stopped for lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hwang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932191
- Sponsor's protocol ID
- DHCrush001
- Status last verified
- Aug 2014
- First submitted
- 1 Jul 2009
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique
- ClinicalTrials.gov ID
- NCT00932191
- Acronym / sponsor ID
- DHCrush001
- Conditions
- Cataracts
- Keywords
- Cataract, Corneal endothelial cell loss, Ultrasound power, Corneal endothelium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for lack of funds
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Jul 2009 (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 purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound phacoemulsification | Active comparator | Procedure: Standard phacoemulsificationCataract nucleus is removed using standard amounts of ultrasound energy. |
| Reduced ultrasound phacoemulsification | Active comparator | Procedure: Reduced ultrasound phacoemulsificationCataract nucleus removal using less ultrasound energy and more mechanical energy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Visually significant moderate density cataract
Key exclusion criteria (4 listed)
- Corneal or retinal pathology limiting visual potential to worse than 20/40
- Lens pathology including pseudoexfoliation or lens dislocation
- Prior intraocular surgery
- Age less than 40
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 |
|---|---|---|
| Standard phacoemulsificationCataract nucleus removal using standard amounts of ultrasound energy | Procedure or surgery | Ultrasound phacoemulsification |
| Reduced ultrasound phacoemulsificationCataract nucleus removal using less ultrasound energy and more mechanical energy. | Procedure or surgery | Reduced ultrasound phacoemulsification |
Primary outcome
Corneal endothelial cell loss by specular microscopy after cataract surgery
Time frame: 3 months post-operatively
Results and safety
The study was stopped early (reason given: Stopped for lack of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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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.
David Hwang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Standard phacoemulsification and Reduced ultrasound phacoemulsification in people with Cataracts, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 25 Aug 2014. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Stopped for lack of funds). Results are not available in the source record.
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?
Corneal endothelial cell loss by specular microscopy after cataract surgery (time frame: 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2014.