CataractNCT04163926
Optometric Follow-up After Cataract Surgery
A study testing Intervention Group cataract follow up in people with Cataract and Age-related Cataract, run by Queen's University, Belfast.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract, Age-related Cataract
- What is being tested?
- Intervention Group cataract follow up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2022to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Optometric Versus Ophthalmic Follow up of Cataract Surgery Patients in Northern Ireland: A Mixed Methods Study
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.
Read the 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.
- Conditions
- Cataract, Age-related Cataract
- Being tested
- Intervention Group cataract follow up, Usual Care consultant follow up
- Keywords
- follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care
- Medical subject headings
- Cataract, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group cataract follow upProcedure or surgery
Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
Usual Care consultant follow upProcedure or surgery
Usual care group - Consultant led post op follow up
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - Post op follow up by trained optometrist | Experimental | Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic Receives: Procedure: Intervention Group cataract follow up |
| Usual care group - Consultant led post op follow up | Active comparator | Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist Receives: Procedure: Usual Care consultant follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months
Secondary outcomes (5)
Cost
The total cost per patient visit will be determined and compared
Measured: 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.
Measured: At 6 months
Intraocular pressure (IOP) rise
IOP rise will be compared between the 2 groups in mmHg
Measured: 6 months
Visual Acuity
Visual acuity will be compared between the 2 groups
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start28 Feb 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion28 Sep 2022 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial (RCT) control versus usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Southern Health and Social Care Trust
- Responsible party
- Principal investigator, Nathan Congdon, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163926
- Sponsor's protocol ID
- B17/29
- Status last verified
- Sep 2022
- First submitted
- 7 Aug 2019
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optometric Versus Ophthalmic Follow up of Cataract Surgery Patients in Northern Ireland: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04163926
- Acronym / sponsor ID
- B17/29
- Conditions
- Cataract, Age-related Cataract
- Keywords
- follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Southern Health and Social Care Trust
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 28 Sep 2022 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised control trial (RCT) control versus usual care
| Arm | Type | Receives |
|---|---|---|
| Intervention group - Post op follow up by trained optometrist | Experimental | Procedure: Intervention Group cataract follow upIntervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic |
| Usual care group - Consultant led post op follow up | Active comparator | Procedure: Usual Care consultant follow upFollow-up at 4-6 weeks after surgery led by consultant ophthalmologist |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group cataract follow upIntervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery | Procedure or surgery | Intervention group - Post op follow up by trained optometrist |
| Usual Care consultant follow upUsual care group - Consultant led post op follow up | Procedure or surgery | Usual care group - Consultant led post op follow up |
Primary outcome
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
Time frame: At 6 months
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
5 secondary outcomes
Cost
Time frame: At 6 months
Patient safety
Time frame: At 6 months
Intraocular pressure (IOP) rise
Time frame: 6 months
Visual Acuity
Time frame: 6 months
Post operative complications
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group cataract follow up in people with Cataract and Age-related Cataract, run by Queen's University, Belfast.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.