Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867189
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hua Liu, Tianjin Medical University Eye Hospital

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.


Condition or disease Intervention/treatment Phase
Cataract Other: atlas of micro-instrument Not Applicable

Detailed Description:
A single surgeon conducted all of the surgery and follow-up all patients

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract
Study Start Date : September 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: atlas of micro-instrument
anterior chamber cell counts and visual and intraocular pressures on postoperative days 1,3,7,14 by atlas of micro-instrument training method.
Other: atlas of micro-instrument
Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery

No Intervention: traditional training
anterior chamber cell counts and visual and intraocular pressures on postoperative days1,3,7,14 by traditional training method.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. the change of vision after cataract surgery [ Time Frame: within the 14 days after surgery ]
    the change of vision after cataract surgery within the 14 days after surgery


Other Outcome Measures:
  1. the change of intraocular pressure after cataract surgery [ Time Frame: within the 14 days after surgery ]
    the change of intraocular pressure after cataract surgery within the 14 days after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cataract patients

Exclusion Criteria:

  • Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.

Layout table for additonal information
Responsible Party: Hua Liu, charge of nursing department, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier: NCT02867189     History of Changes
Other Study ID Numbers: tjykdxykyy5
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hua Liu, Tianjin Medical University Eye Hospital:
anterior chamber flare
cataract
intraocular pressure
micro-instrument
photograph-based atlas
visual
training nurse

Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases