An interventional study of Intervention Group cataract follow up and Usual Care consultant follow up in Cataract and Age-related Cataract, sponsored by Queen's University, Belfast. Withdrawn. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Health services research
This study will investigate the effectiveness of an optometric follow up of cataract surgery versus an ophthalmic surgeon follow up. It will investigate patient satisfaction,safety and cost.
The study will be a mixed-methods study, including a randomized controlled trial in which participants are randomized after cataract surgery to follow up to be consultant led follow up or conducted by a trained optometrist 4-6 weeks following surgery. All participants will then return 6 months after surgery for an additional follow-up visit with an ophthalmologist other than the operating surgeon with patient healthcare satisfaction (main outcome), cost-effectiveness and safety outcomes being measured. A subset of patients and local clinicians will also take part in a one-time, individual, semi-structured interview.
This research will test an alternative model of aftercare for cataract surgeries, which may reduce patient waiting time and inconvenience. In turn, this could help improve patient satisfaction and reduce costs for both patients and the National Health Service (NHS).
Participants will be recruited by operating surgeons. The research will take place in the hospital/clinic/optometrists' offices.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
Browse Cataract studies →Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic
Procedure: Intervention Group cataract follow up
Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist
Procedure: Usual Care consultant follow up
Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
Usual care group - Consultant led post op follow up
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
Patient satisfaction will be measured using the patient satisfaction questionnaire (PSQ)-18 at 6 months after surgery The scale include values for general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor and accessibility and convenience. Each question is scored between 1 - 5. As some questions have reverse scoring (higher values indicate dissatisfaction) scores are reversed so a 5 will show highest satisfaction and 1 show lowest satisfaction. Each item within the subscales will be averaged and results will be given for each of the 7 subscales
Time frame: At 6 months
Cost
The total cost per patient visit will be determined and compared
Time frame: At 6 months
Patient safety
Patient safety outcomes in the operative eye will include: loss of visual acuity \>=2 lines Intraocular pressure (IOP) rise \>=8 millimetres of mercury (mmHg) post-operative complications as documented by the examining ophthalmologist.
Time frame: At 6 months
Intraocular pressure (IOP) rise
IOP rise will be compared between the 2 groups in mmHg
Time frame: 6 months
Visual Acuity
Visual acuity will be compared between the 2 groups
Time frame: 6 months
Post operative complications
Post operative complications will be assessed qualitatively. Surgeons at the 6 month follow up will detail if cornea deep and quiet, wound is intact, intraocular lens centred, posterior capsule intact and clear, anterior vitreous quiet, posterior pole and retina remarkable, signs if infection, retained ens matter and other abnormalities recorded by the surgeon.
Time frame: 6 months
Adherence
How well patients that have had cataract surgery follow advice for at home care (use of post-operative medication, self-report) and attending follow up medical appointments (as per patient records) will also be compared between the two groups.
Time frame: At 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Queen's University, Belfast