CataractNCT01305005
Effect of Phacoemulsification on Ocular Blood Flow in Human
An observational study of Cataract and Hypertension, run by yin ying zhao at 1 site in China.
Trial summary
To investigate ocular haemodynamics after phacoemulsification surgery To evaluate the influence in people with different autoregulation of ocular blood flow Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Hypertension, Diabetes
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to 10 Jun 2019
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical College
Who may be able to join
- age-related cataract
- no complications during surgery
Who cannot join
- complications during surgery
- have other complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate Ocular Haemodynamics After Phacoemulsification Surgery
- To investigate ocular haemodynamics after phacoemulsification surgery
- To evaluate the influence in people with different autoregulation of ocular blood flow
- Conditions
- Cataract, Hypertension, Diabetes
- Keywords
- blood flow
- Medical subject headings
- Cataract, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with active-fluidics system | patients who underwent phacoemulsification surgery using active-fluidics system | |
| patients with gravity-fluidics system. | patients who underwent phacoemulsification surgery using gravity-fluidics system |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2018
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- yin ying zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yin ying zhao, Wenzhou Medical University
- Investigators
- qu jia, MD, Principal investigator, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305005
- Sponsor's protocol ID
- WZMC2011BNZYJ
- Status last verified
- Jul 2019
- First submitted
- 25 Feb 2011
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhao Y, Wang D, Nie L, Yu Y, Zou R, Li Z, Xu M, Zhao Y. Early changes in retinal microcirculation after uncomplicated cataract surgery using an active-fluidics system. Int Ophthalmol. 2021 May;41(5):1605-1612. doi: 10.1007/s10792-021-01694-4. Epub 2021 Feb 6.
PubMed 33547997
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Ocular Haemodynamics After Phacoemulsification Surgery
- ClinicalTrials.gov ID
- NCT01305005
- Acronym / sponsor ID
- WZMC2011BNZYJ
- Conditions
- Cataract, Hypertension, Diabetes
- Keywords
- blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- yin ying zhaoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2018 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 28 Feb 2011 (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 ocular haemodynamics after phacoemulsification surgery
- To evaluate the influence in people with different autoregulation of ocular blood flow
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with active-fluidics system | – | –patients who underwent phacoemulsification surgery using active-fluidics system |
| patients with gravity-fluidics system. | – | –patients who underwent phacoemulsification surgery using gravity-fluidics system |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical College
Key inclusion criteria (2 listed)
- age-related cataract
- no complications during surgery
Key exclusion criteria (2 listed)
- complications during surgery
- have other complications
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
Not reported in the source record.
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 30 Jul 2019.
- Derived from this study: PubMed 33547997Zhao Y, Wang D, Nie L, Yu Y, Zou R, Li Z, Xu M, Zhao Y. Early changes in retinal microcirculation after uncomplicated cataract surgery using an active-fluidics system. Int Ophthalmol. 2021 May;41(5):1605-1612. doi: 10.1007/s10792-021-01694-4. Epub 2021 Feb 6.
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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.
qu jia, 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 Hypertension, run by yin ying zhao 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 2 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 30 Jul 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305005, which also lists 1 linked publication.
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 30 Jul 2019.