Capsular Bag Distention Syndrome After Cataract SurgeryNCT01868217
A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors
An observational study of Capsular Bag Distention Syndrome After Cataract Surgery, run by Evidence Based Cataract Study Group.
Trial summary
To Investigate the Prevalence of Capsular Bag Distention Syndrome To Analyze Influencing Factors of Capsular Bag Distention Syndrome Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Capsular Bag Distention Syndrome After Cataract Surgery
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2013
- Phase
- Observational
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Who Underwent Cataract Surgery at Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China
Who may be able to join
- patients who underwent uneventful phacoemulsification and posterior-chamber IOL implantation at the Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China, between November 2011 and December 2012
Who cannot join
- Patients with traumatic cataracts or zonular weakness were excluded from the study, as were eyes with intraoperative complications, such as a posterior capsule opening, radial tearing of the continuous curvilinear capsulorhexis (CCC), or inappropriate IOL implantation.
About this study
- To Investigate the Prevalence of Capsular Bag Distention Syndrome
- To Analyze Influencing Factors of Capsular Bag Distention Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimension of the eyeball(mm)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsular Bag Distention Syndrome After Cataract SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidence Based Cataract Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868217
- Sponsor's protocol ID
- NSFC-81100653
- Status last verified
- May 2013
- First submitted
- 27 May 2013
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors
- ClinicalTrials.gov ID
- NCT01868217
- Acronym / sponsor ID
- NSFC-81100653
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Evidence Based Cataract Study GroupUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- First posted
- 4 Jun 2013 (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.
- To Investigate the Prevalence of Capsular Bag Distention Syndrome
- To Analyze Influencing Factors of Capsular Bag Distention Syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Who Underwent Cataract Surgery at Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China
Key inclusion criteria (1 listed)
- patients who underwent uneventful phacoemulsification and posterior-chamber IOL implantation at the Eye and ENT Hospital of Fudan University, Xuhui, Shanghai, China, between November 2011 and December 2012
Key exclusion criteria (1 listed)
- Patients with traumatic cataracts or zonular weakness were excluded from the study, as were eyes with intraoperative complications, such as a posterior capsule opening, radial tearing of the continuous curvilinear capsulorhexis (CCC), or inappropriate IOL implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dimension of the eyeball(mm)
Time frame: 1 month
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 4 Jun 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Capsular Bag Distention Syndrome After Cataract Surgery, run by Evidence Based Cataract Study Group.
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 1 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Dimension of the eyeball(mm) (time frame: 1 month). 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 4 Jun 2013.