CataractNCT00432874
Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration
A study testing wound hydration method in people with Cataract, run by University of Utah at 1 site in United States.
Trial summary
The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- wound hydration method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Visually significant cataract requiring surgery
Who cannot join
- Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
- Any intraoperative complications
- Cataract incision length < 1 mm
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration
The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.
- Conditions
- Cataract
- Being tested
- wound hydration method
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound hydration methodProcedure or surgery
Anterior vs lateral wound hydration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Anterior stromal hydration ("Wong" method) Receives: Procedure: wound hydration method |
| 2 | Active comparator | Traditional lateral wound hydration Receives: Procedure: wound hydration method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with wound leakage at the end of surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Mark D Mifflin, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432874
- Sponsor's protocol ID
- UT16122
- Status last verified
- Oct 2010
- First submitted
- 6 Feb 2007
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Safety and Efficacy of Two Forms of Corneal Stromal Hydration
- ClinicalTrials.gov ID
- NCT00432874
- Acronym / sponsor ID
- UT16122
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Feb 2007 (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 study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: wound hydration methodAnterior stromal hydration ("Wong" method) |
| 2 | Active comparator | Procedure: wound hydration methodTraditional lateral wound hydration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Visually significant cataract requiring surgery
Key exclusion criteria (4 listed)
- Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
- Any intraoperative complications
- Cataract incision length < 1 mm
- Pregnancy
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 |
|---|---|---|
| wound hydration methodAnterior vs lateral wound hydration | Procedure or surgery | 1, 2 |
Primary outcome
Proportion of eyes with wound leakage at the end of surgery
Time frame: Intraoperative
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 19 Oct 2010.
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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.
Mark D Mifflin, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound hydration method in people with Cataract, run by University of Utah 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: finished, as of the sponsor's last update on 19 Oct 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 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.
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?
Proportion of eyes with wound leakage at the end of surgery (time frame: Intraoperative). 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 19 Oct 2010.