CataractAOACCCAPNCT02238002
Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification
An observational study of Cataract and Shallow Anterior Chamber, run by Zheng Qian at 1 site in China.
Trial summary
To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT). Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Shallow Anterior Chamber, Narrow Angle
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Mar 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical University
Who may be able to join
- ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .
Who cannot join
- primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Qian Zheng, 18367839685, zq15.04@163.com
About this study
Official title: To Investigate Changes in Anterior Chamber Angle Configuration After Phacoemulsification
To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).
Read the detailed description
To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle, compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical Coherence Tomography (SS-OCT).
- Conditions
- Cataract, Shallow Anterior Chamber, Narrow Angle
- Being tested
- cataract surgery
- Keywords
- shallow anterior chamber, narrow angle, SS-OCT
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
The patients of both groups underwent cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| normal angle | normal anterior chamber and open angle eyes underwent cataract surgery Receives: Procedure: cataract surgery | |
| narrow angle | shallow anterior chamber and narrow angle eyes underwent cataract surgery Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior chamber angle parameters increased
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMar 2015 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Qian, Wenzhou Medical University
- Investigators
- Yun e Zhao, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238002
- Sponsor's protocol ID
- WZMC2013QQFYJ
- Acronym
- AOACCCAP
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Changes in Anterior Chamber Angle Configuration After Phacoemulsification
- ClinicalTrials.gov ID
- NCT02238002
- Acronym / sponsor ID
- AOACCCAP / WZMC2013QQFYJ
- Conditions
- Cataract, Shallow Anterior Chamber, Narrow Angle
- Keywords
- shallow anterior chamber, narrow angle, SS-OCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zheng QianUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Sep 2014 (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 changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).
Detailed description
To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle, compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical Coherence Tomography (SS-OCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal angle | – | Procedure: cataract surgerynormal anterior chamber and open angle eyes underwent cataract surgery |
| narrow angle | – | Procedure: cataract surgeryshallow anterior chamber and narrow angle eyes underwent cataract surgery |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical University
Key inclusion criteria (1 listed)
- ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .
Key exclusion criteria (1 listed)
- primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries
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 |
|---|---|---|
| cataract surgeryThe patients of both groups underwent cataract surgery | Procedure or surgery | narrow angle, normal angle |
Primary outcome
anterior chamber angle parameters increased
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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.
Yun e Zhao, MD principal investigator
Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Shallow Anterior Chamber, run by Zheng Qian 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 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: status not confirmed, as of the sponsor's last update on 12 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Zheng, MD (18367839685, zq15.04@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior chamber angle parameters increased (time frame: 1 year). 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 12 Sep 2014.