CataractNCT02071147
RCT of Follow up Following Cataract Extraction
A study testing No Clinical Follow up, Quality of Life questionnaire and Patient satisfaction Questionnaire in people with Cataract, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Purpose: To examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery. Background: Approximately 300000 cataract extractions are performed annually in the NHS in England, requiring a similar number of post-operative visits, the majority of which result in… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- No Clinical Follow up, Quality of Life questionnaire and Patient satisfaction Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to 10 Aug 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults Aged >= 40 years
- Scheduled for day-case cataract surgery
- Able to give informed consent
Who cannot join
- Unable to provide written informed consent
- Unable to visit their optometrist post operatively
- Patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within three months of their operation (including significant diabetic retinopathy, wet age-related macular degeneration (AMD) on treatment, severe/end-stage glaucoma, previous retinal detachment or vitrectomy)
- Patients undergoing another simultaneous ophthalmic procedure
- Patients who suffer from an intra-operative complication requiring early postoperative evaluation (identified at surgery).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Torbay District General Hospital
Torquay, Devon, TQ2 7AA
About this study
Official title: Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction
Purpose:
To examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery.
Read more
Background:
Approximately 300000 cataract extractions are performed annually in the NHS in England, requiring a similar number of post-operative visits, the majority of which result in no change in management. A conservative estimate of 70% of visits being unnecessary suggests a potential saving to the NHS of approximately £10M annually.
What's involved:
The study involves some questionnaires during the duration of the study. These include questionnaires relating to the quality of life of the patient (conducted before the operation, and at the 3 month research clinic) and a patient satisfaction questionnaire. There is also a research clinic 3 months following the operation.
What are the risks/benefits:
There are no real personal benefits to patients on the trial. The trial aims to provide very important information regarding the safety of discharging patients immediately after surgery. However the trial could potentially save many thousands of unnecessary hospital visits each year.
Read the detailed description
Method:
The method presented is based on the method employed successfully by one of the applicants in an earlier stuy of the first day postoperative review following cataract surgery which has been peer-reviewed and published in the scientific literature. An earlier draft has been presented to a patient panel and has the benefit of external review by a potential steering group.
Patients undergoing routine elective phacoemulsification cataract surgery will be randomly assigned to either a routine review at 4-6 weeks post-operatively (routine care) or to be discharged from the cataract service immediately post-operatively. All patients will be advised to see their own optometrist at 4-6 weeks for new spectacles if appropriate and will then be reviewed in a research clinic at 3 months post operatively.
- Conditions
- Cataract
- Being tested
- No Clinical Follow up, Quality of Life questionnaire, Patient satisfaction Questionnaire
- Keywords
- Follow-up, No follow-up, removal, Randomised Controlled Trial, 6 Weeks
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Clinical Follow upOther
Quality of Life questionnaireOther
Also called VQOL
Patient satisfaction QuestionnaireOther
Conducted at Research clinic.
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical intervention | Other | Patients reviewed at 6 weeks (+/- 1 week) as is our normal practice and recalled for a further evaluation if deemed appropriate. Patients will be instructed to visit their optometrist once their eye has fully recovered from the operation for provision of glasses. Receives: Other: Quality of Life questionnaire; Other: Patient satisfaction Questionnaire |
| No Clinical Follow up | Other | No routine follow-up appointment is made. Patients will be instructed to visit their optometrist between 6-8 weeks post-operative for review of the patient's glasses. Receives: Other: No Clinical Follow up; Other: Quality of Life questionnaire; Other: Patient satisfaction Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity (VA)
Measured: 3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Measured: 3 Months
Secondary outcomes (2)
Post operative complication rate between the two groups
Measured: 3 Months
Post operative patient satisfaction between the two groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion10 Aug 2016
- Study completion10 Aug 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torbay and South Devon NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Frost, MBchB, MRCP, FRCOphth, PHD, Principal investigator, Torbay and South Devon NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071147
- Sponsor's protocol ID
- 14/02/050
- Status last verified
- Nov 2024
- First submitted
- 21 Feb 2014
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction
- ClinicalTrials.gov ID
- NCT02071147
- Acronym / sponsor ID
- 14/02/050
- Conditions
- Cataract
- Keywords
- Follow-up, No follow-up, removal, Randomised Controlled Trial, 6 Weeks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Torbay and South Devon NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 25 Feb 2014 (estimated)
- 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.
Purpose:
To examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery.
Background:
Approximately 300000 cataract extractions are performed annually in the NHS in England, requiring a similar number of post-operative visits, the majority of which result in no change in management. A conservative estimate of 70% of visits being unnecessary suggests a potential saving to the NHS of approximately £10M annually.
What's involved:
The study involves some questionnaires during the duration of the study. These include questionnaires relating to the quality of life of the patient (conducted before the operation, and at the 3 month research clinic) and a patient satisfaction questionnaire. There is also a research clinic 3 months following the operation.
What are the risks/benefits:
There are no real personal benefits to patients on the trial. The trial aims to provide very important information regarding the safety of discharging patients immediately after surgery. However the trial could potentially save many thousands of unnecessary hospital visits each year.
Detailed description
Method:
The method presented is based on the method employed successfully by one of the applicants in an earlier stuy of the first day postoperative review following cataract surgery which has been peer-reviewed and published in the scientific literature. An earlier draft has been presented to a patient panel and has the benefit of external review by a potential steering group.
Patients undergoing routine elective phacoemulsification cataract surgery will be randomly assigned to either a routine review at 4-6 weeks post-operatively (routine care) or to be discharged from the cataract service immediately post-operatively. All patients will be advised to see their own optometrist at 4-6 weeks for new spectacles if appropriate and will then be reviewed in a research clinic at 3 months post operatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clinical intervention | Other | Other: Quality of Life questionnaire, Other: Patient satisfaction QuestionnairePatients reviewed at 6 weeks (+/- 1 week) as is our normal practice and recalled for a further evaluation if deemed appropriate. Patients will be instructed to visit their optometrist once their eye has fully recovered from the operation for provision of glasses. |
| No Clinical Follow up | Other | Other: No Clinical Follow up, Other: Quality of Life questionnaire, Other: Patient satisfaction QuestionnaireNo routine follow-up appointment is made. Patients will be instructed to visit their optometrist between 6-8 weeks post-operative for review of the patient's glasses. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults Aged >= 40 years
- Scheduled for day-case cataract surgery
- Able to give informed consent
Key exclusion criteria (5 listed)
- Unable to provide written informed consent
- Unable to visit their optometrist post operatively
- Patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within three months of their operation (including significant diabetic retinopathy, wet age-related macular degeneration (AMD) on treatment, severe/end-stage glaucoma, previous retinal detachment or vitrectomy)
- Patients undergoing another simultaneous ophthalmic procedure
- Patients who suffer from an intra-operative complication requiring early postoperative evaluation (identified at surgery).
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 |
|---|---|---|
| No Clinical Follow up | Other | No Clinical Follow up |
| Quality of Life questionnaireAlso: VQOL | Other | No Clinical Follow up, Standard clinical intervention |
| Patient satisfaction QuestionnaireConducted at Research clinic. | Other | No Clinical Follow up, Standard clinical intervention |
Primary outcome
Corrected distance visual acuity (VA)
Time frame: 3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Time frame: 3 Months
2 secondary outcomes
Post operative complication rate between the two groups
Time frame: 3 Months
Post operative patient satisfaction between the two groups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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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.
Andrew Frost, MBchB, MRCP, FRCOphth, PHD principal investigator
Torbay and South Devon NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Clinical Follow up, Quality of Life questionnaire and Patient satisfaction Questionnaire in people with Cataract, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Corrected distance visual acuity (VA) (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 29 Nov 2024.