NCT02867189

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

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

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

August 2, 2016

Last Update Submit

August 11, 2016

Conditions

Keywords

anterior chamber flarecataractintraocular pressuremicro-instrumentphotograph-based atlasvisualtraining nurse

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

EXPERIMENTAL

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

traditional training

NO INTERVENTION

anterior 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

atlas of micro-instrument

Eligibility Criteria

Age60 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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