CataractNCT01146964
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
A study testing MSSICS and Phacoemulsification in people with Cataract and Phacoemulsification, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract, Phacoemulsification
- What is being tested?
- MSSICS and Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jun 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age related cataract patients
- Cataract density grade II-III according to the Emery-Little system classification system
Who cannot join
- Legal guardian(s) is/are not present for permission
- Other eye diseases impairing visual acuity (ie. glaucoma)
- patients with severe systemic diseases not good for ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.
- Conditions
- Cataract, Phacoemulsification
- Being tested
- MSSICS, Phacoemulsification
- Keywords
- Age related cataract, Phacoemulsification, Manual super small incision cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSSICSProcedure or surgery
Manual super small incision cataract surgery
PhacoemulsificationProcedure or surgery
cataract surgery with Phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Phacoemulsification, Safety, Efficacy | Experimental | Not described Receives: Procedure: Phacoemulsification |
| MSSICS, Safety, Efficacy | Experimental | Not described Receives: Procedure: MSSICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal endothelial cell loss
Measured: 3 months postoperatively
Secondary outcomes (2)
postoperative astigmatism
Measured: 3 months postoperatively
visual acuity
Measured: 3 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangtian Zhou, Wenzhou Medical University
- Investigators
- Wei Chen, MD, PhD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146964
- Sponsor's protocol ID
- 10003
- Status last verified
- Jan 2014
- First submitted
- 2 Jun 2010
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
- ClinicalTrials.gov ID
- NCT01146964
- Acronym / sponsor ID
- 10003
- Conditions
- Cataract, Phacoemulsification
- Keywords
- Age related cataract, Phacoemulsification, Manual super small incision cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Jun 2010 (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 the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phacoemulsification, Safety, Efficacy | Experimental | Procedure: Phacoemulsification |
| MSSICS, Safety, Efficacy | Experimental | Procedure: MSSICS |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age related cataract patients
- Cataract density grade II-III according to the Emery-Little system classification system
Key exclusion criteria (3 listed)
- Legal guardian(s) is/are not present for permission
- Other eye diseases impairing visual acuity (ie. glaucoma)
- patients with severe systemic diseases not good for ocular surgery
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 |
|---|---|---|
| MSSICSManual super small incision cataract surgery | Procedure or surgery | MSSICS, Safety, Efficacy |
| Phacoemulsificationcataract surgery with Phacoemulsification | Procedure or surgery | Phacoemulsification, Safety, Efficacy |
Primary outcome
Corneal endothelial cell loss
Time frame: 3 months postoperatively
2 secondary outcomes
postoperative astigmatism
Time frame: 3 months postoperatively
visual acuity
Time frame: 3 month 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 3 Jan 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.
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 MSSICS and Phacoemulsification in people with Cataract and Phacoemulsification, 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 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 3 Jan 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 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?
Corneal endothelial cell loss (time frame: 3 months postoperatively). 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 3 Jan 2014.