Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety
1 other identifier
interventional
120
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedAugust 15, 2016
October 1, 2015
Same day
August 2, 2016
August 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the numbers of anterior chamber cells after cataract surgery.
the numbers of anterior chamber cell counts within the 14 days after surgery
within the 14 days after surgery
Secondary Outcomes (1)
the change of vision after cataract surgery
within the 14 days after surgery
Other Outcomes (1)
the change of intraocular pressure after cataract surgery
within the 14 days after surgery
Study Arms (2)
atlas of micro-instrument
EXPERIMENTALanterior 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 INTERVENTIONanterior chamber cell counts and visual and intraocular pressures on postoperative days1,3,7,14 by traditional training method.
Interventions
Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery
Eligibility Criteria
You may qualify if:
- Cataract patients
You may not qualify if:
- Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hua Liulead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- charge of nursing department
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 15, 2016
Study Start
September 1, 2015
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
August 15, 2016
Record last verified: 2015-10
Data Sharing
- IPD Sharing
- Will not share