Independent Prescribing Optometrists in Acute Ophthalmic Services
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|ClinicalTrials.gov Identifier: NCT02585063|
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : January 14, 2021
The UK government's Crown report titled 'Review of prescribing, supply & administration of medicines' enabled optometrists to train for the qualification of independent prescribing (IP). The UK introduced IP for optometrists in 2009. The proposed research focuses on the role of IP optometrist in the acute ophthalmic services of Manchester Royal Eye Hospital (MREH). The study will compare IP optometrists to consultant ophthalmologists in the ability to diagnose, manage and prescribe medication for patients accessing these services.
To achieve this comparison consenting participants will first have a clinical assessment with the IP Optometrist, where findings including diagnosis and management plan will be recorded onto a research proforma. The consultant ophthalmologist will be masked to the IP Optometrist's research proforma to prevent bias. The consultant ophthalmologist will then perform a clinical assessment on a second proforma and inform the participant of their diagnosis and management plan. Percentage agreement, kappa (κ) and weighted κ will be calculated for a range of parameters between the two proformas. Disagreement in diagnosis or management will be arbitrated by a separate ophthalmologist participating in the study with a specialty relevant to the participant's condition.
The main objective of the research is to expand the limited base of evidence of of IP optometrists' ability to diagnose, manage and prescribe medication and to determine whether they work at least as safely and effectively as consultant ophthalmologists in acute ophthalmic services. It is the first study in this area since the advent of IP for optometrists, with only one previous study published before IP was introduced. The research will enable the type and frequency of conditions presenting in these services to be measured. Furthermore it will identify conditions that IP optometrists can manage independently and enable guidelines for these conditions to be developed.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||321 participants|
|Official Title:||Independent Prescribing Optometrists in Acute Ophthalmic Services|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||December 13, 2017|
|Actual Study Completion Date :||September 12, 2018|
Where there is time and space, participants will be allocated to have a clinical assessment by the IP optometrist during their wait for the clinical assessment with the ophthalmologist. Both clinical assessments are needed to obtain measurement of agreement. There is no intervention. but participants have two clinical assessments rather than just one.
- Prescribing decision [ Time Frame: Through study completion - up to 18 months ]The prescribing decisions of ophthalmologists and optometrists will be compared. They will be documented via self-reports.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585063
|Manchester Royal Eye Hospital|
|Manchester, United Kingdom, M13 9WL|
|Study Chair:||Cindy Tromans, PhD||Manchester Royal Eye Hospital|