- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02867189
Developing an Atlas to Teach Nurses to Clean Micro-instruments Used in Cataract Surgery: Effect on Patient Safety
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.
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Cataract patients
Exclusion Criteria:
- Patients with metabolic disease, immune disease, and/or retinopathy were not included in this study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery
|
|
Inget ingripande: traditional training
anterior chamber cell counts and visual and intraocular pressures on postoperative days1,3,7,14 by traditional training method.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the numbers of anterior chamber cells after cataract surgery.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the change of vision after cataract surgery
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the change of intraocular pressure after cataract surgery
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- tjykdxykyy5
Plan för individuella deltagardata (IPD)
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