search
Back to results

Optometric Follow-up After Cataract Surgery

Primary Purpose

Cataract, Age-related Cataract

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Group cataract follow up
Usual Care consultant follow up
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract focused on measuring follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the Belfast Trust and Southern Trust
  • Willing to participate and give informed consent.

Exclusion Criteria:

  • Patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). Note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients.
  • Patients that were not referred by an optometrist.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group - Post op follow up by trained optometrist

    Usual care group - Consultant led post op follow up

    Arm Description

    Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic

    Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Cost
    The total cost per patient visit will be determined and compared
    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.
    Intraocular pressure (IOP) rise
    IOP rise will be compared between the 2 groups in mmHg
    Visual Acuity
    Visual acuity will be compared between the 2 groups
    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.

    Full Information

    First Posted
    August 7, 2019
    Last Updated
    September 13, 2022
    Sponsor
    Queen's University, Belfast
    Collaborators
    Belfast Health and Social Care Trust, Southern Health and Social Care Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04163926
    Brief Title
    Optometric Follow-up After Cataract Surgery
    Official Title
    Optometric Versus Ophthalmic Follow up of Cataract Surgery Patients in Northern Ireland: A Mixed Methods Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The RCT part of the study has been stopped. Due to other issues, funding, other trails and policy changes, the rct will not happen. Interviews will continue but RCT part will not.
    Study Start Date
    February 28, 2022 (Anticipated)
    Primary Completion Date
    August 30, 2022 (Anticipated)
    Study Completion Date
    September 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University, Belfast
    Collaborators
    Belfast Health and Social Care Trust, Southern Health and Social Care Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Age-related Cataract
    Keywords
    follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised control trial (RCT) control versus usual care
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessor will not know the study group assignment of participants.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group - Post op follow up by trained optometrist
    Arm Type
    Experimental
    Arm Description
    Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic
    Arm Title
    Usual care group - Consultant led post op follow up
    Arm Type
    Active Comparator
    Arm Description
    Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist
    Intervention Type
    Procedure
    Intervention Name(s)
    Intervention Group cataract follow up
    Intervention Description
    Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Usual Care consultant follow up
    Intervention Description
    Usual care group - Consultant led post op follow up
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Cost
    Description
    The total cost per patient visit will be determined and compared
    Time Frame
    At 6 months
    Title
    Patient safety
    Description
    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
    Title
    Intraocular pressure (IOP) rise
    Description
    IOP rise will be compared between the 2 groups in mmHg
    Time Frame
    6 months
    Title
    Visual Acuity
    Description
    Visual acuity will be compared between the 2 groups
    Time Frame
    6 months
    Title
    Post operative complications
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Adherence
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the Belfast Trust and Southern Trust Willing to participate and give informed consent. Exclusion Criteria: Patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). Note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients. Patients that were not referred by an optometrist.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Optometric Follow-up After Cataract Surgery

    We'll reach out to this number within 24 hrs