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

August 11, 2016 updated by: Hua Liu

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 14 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 14 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the 14 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tjykdxykyy5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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