CataractNCT02867189
Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety
A study testing atlas of micro-instrument in people with Cataract, run by Hua Liu.
Trial summary
Aims and objectives The purpose of this study was to develop an atlas to explore the effect of micro-instrument cleaning on the safety of cataract surgery. Background Cataract surgery safety is affected by many factors, the most influential of which is the quality of instrument cleaning. Read more about this study
- Who is it for?
- Ages 60 to 88 years
- Conditions the study is for
- Cataract
- What is being tested?
- atlas of micro-instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Oct 2015
- 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 60 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract patients
Who cannot join
- Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.
About this study
Official title: Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract
Aims and objectives The purpose of this study was to develop an atlas to explore the effect of micro-instrument cleaning on the safety of cataract surgery.
Background Cataract surgery safety is affected by many factors, the most influential of which is the quality of instrument cleaning. Previous studies focused on the reaction in the eye after cataract surgery. None offered a solution for manually cleaning ophthalmic micro-instruments or response data for surgical instruments after cataract surgery.
Read more
Design The study was designed to collect quantitative data derived from postoperative ocular evaluation.
Methods We developed an atlas that details micro-instrument cleaning that could be used to train nurses to have this skill. A total of 120 cataract patients were divided evenly into experimental and control groups. In the experimental group, cataract surgery was undertaken using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the patients underwent the same postoperative tests: anterior chamber cell counts and visual and intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.
Read the detailed description
A single surgeon conducted all of the surgery and follow-up all patients
- Conditions
- Cataract
- Being tested
- atlas of micro-instrument
- Keywords
- anterior chamber flare, cataract, intraocular pressure, micro-instrument, photograph-based atlas, visual, training nurse
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atlas of micro-instrumentOther
Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| atlas of micro-instrument | Experimental | anterior chamber cell counts and visual and intraocular pressures on postoperative days 1,3,7,14 by atlas of micro-instrument training method. Receives: Other: atlas of micro-instrument |
| traditional training | No intervention | anterior chamber cell counts and visual and intraocular pressures on postoperative days1,3,7,14 by traditional training method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the numbers of anterior chamber cells after cataract surgery.
the numbers of anterior chamber cell counts within the 14 days after surgery
Measured: within the 14 days after surgery
Secondary outcomes (1)
the change of vision after cataract surgery
the change of vision after cataract surgery within the 14 days after surgery
Measured: within the 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionOct 2015
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Liu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867189
- Sponsor's protocol ID
- tjykdxykyy5
- Status last verified
- Oct 2015
- First submitted
- 2 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract
- ClinicalTrials.gov ID
- NCT02867189
- Acronym / sponsor ID
- tjykdxykyy5
- Conditions
- Cataract
- Keywords
- anterior chamber flare, cataract, intraocular pressure, micro-instrument, photograph-based atlas, visual, training nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hua LiuUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Aug 2016 (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.
Aims and objectives The purpose of this study was to develop an atlas to explore the effect of micro-instrument cleaning on the safety of cataract surgery.
Background Cataract surgery safety is affected by many factors, the most influential of which is the quality of instrument cleaning. Previous studies focused on the reaction in the eye after cataract surgery. None offered a solution for manually cleaning ophthalmic micro-instruments or response data for surgical instruments after cataract surgery.
Design The study was designed to collect quantitative data derived from postoperative ocular evaluation.
Methods We developed an atlas that details micro-instrument cleaning that could be used to train nurses to have this skill. A total of 120 cataract patients were divided evenly into experimental and control groups. In the experimental group, cataract surgery was undertaken using microsurgical instruments that were cleaned by the atlas-trained nurses. In the control group, micro-instruments were used that had been cleaned by non-atlas-trained nurses. All the patients underwent the same postoperative tests: anterior chamber cell counts and visual and intraocular pressures on postoperative days (PODs) 1, 3, 7, and 14.
Detailed description
A single surgeon conducted all of the surgery and follow-up all patients
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atlas of micro-instrument | Experimental | Other: atlas of micro-instrumentanterior chamber cell counts and visual and intraocular pressures on postoperative days 1,3,7,14 by atlas of micro-instrument training method. |
| traditional training | No intervention | –anterior chamber cell counts and visual and intraocular pressures on postoperative days1,3,7,14 by traditional training method. |
Who may qualify
- Ages
- 60 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cataract patients
Key exclusion criteria (1 listed)
- Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.
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 |
|---|---|---|
| atlas of micro-instrumentNurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery | Other | atlas of micro-instrument |
Primary outcome
the numbers of anterior chamber cells after cataract surgery.
Time frame: within the 14 days after surgery
the numbers of anterior chamber cell counts within the 14 days after surgery
1 secondary outcome
the change of vision after cataract surgery
Time frame: within the 14 days after surgery
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 15 Aug 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing atlas of micro-instrument in people with Cataract, run by Hua Liu.
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 15 Aug 2016. 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?
the numbers of anterior chamber cells after cataract surgery. (time frame: within the 14 days after surgery). 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 15 Aug 2016.