CataractNCT01023334
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
A study testing MSICS under topical anesthesia with intracameral lidocaine and MSICS under topical anesthesia with intracameral balanced salt solution. in people with Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- MSICS under topical anesthesia with intracameral lidocaine and MSICS under topical anesthesia with intracameral balanced salt solution.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Feb 2010
- 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
- Both men and women
- Cataract density grade III-V according to the Emery-Little system classification system
- Patients need to do manual small incision cataract surgery
Who cannot join
- Legal guardian(s) is/are not present for permission
- Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
- Patients with altered levels of pain perceptions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.
- Conditions
- Cataract
- Being tested
- MSICS under topical anesthesia with intracameral lidocaine, MSICS under topical anesthesia with intracameral balanced salt solution.
- Keywords
- Topical analgesia, FlACC Pain Scale, intracameral lignocaine, Anesthetics, Physiological Effects of Drugs, Lidocaine
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSICS under topical anesthesia with intracameral lidocaineProcedure or surgery
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine
MSICS under topical anesthesia with intracameral balanced salt solution.Procedure or surgery
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.
| Study group | Role | What they receive |
|---|---|---|
| Intraocular lidocaine,topical anesthesia,MSICS | Experimental | experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine Receives: Procedure: MSICS under topical anesthesia with intracameral lidocaine |
| intracameral balanced salt solution,topical anesthesia,MSICS | Experimental | control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution. Receives: Procedure: MSICS under topical anesthesia with intracameral balanced salt solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
observed levels of pain
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Wei Chen, MD,PhD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023334
- Sponsor's protocol ID
- 10002
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
- ClinicalTrials.gov ID
- NCT01023334
- Acronym / sponsor ID
- 10002
- Conditions
- Cataract
- Keywords
- Topical analgesia, FlACC Pain Scale, intracameral lignocaine, Anesthetics, Physiological Effects of Drugs, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Dec 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 determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraocular lidocaine,topical anesthesia,MSICS | Experimental | Procedure: MSICS under topical anesthesia with intracameral lidocaineexperimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine |
| intracameral balanced salt solution,topical anesthesia,MSICS | Experimental | Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Both men and women
- Cataract density grade III-V according to the Emery-Little system classification system
- Patients need to do manual small incision cataract surgery
Key exclusion criteria (3 listed)
- Legal guardian(s) is/are not present for permission
- Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
- Patients with altered levels of pain perceptions
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 |
|---|---|---|
| MSICS under topical anesthesia with intracameral lidocainemanual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine | Procedure or surgery | Intraocular lidocaine,topical anesthesia,MSICS |
| MSICS under topical anesthesia with intracameral balanced salt solution.manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution. | Procedure or surgery | intracameral balanced salt solution,topical anesthesia,MSICS |
Primary outcome
observed levels of pain
Time frame: one day
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 2 Aug 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.
Wei Chen, MD,PhD principal investigator
Eye Hospital, Wenzhou Medical College, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSICS under topical anesthesia with intracameral lidocaine and MSICS under topical anesthesia with intracameral balanced salt solution. in people with Cataract, run by Wenzhou Medical University at 1 site in China.
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 3 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 2 Aug 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 China. 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?
observed levels of pain (time frame: one day). 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 2 Aug 2010.