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RCT of Follow up Following Cataract Extraction

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ClinicalTrials.gov Identifier: NCT02071147
Recruitment Status : Unknown
Verified May 2015 by Torbay and South Devon NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
Torbay and South Devon NHS Foundation Trust

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Cataract Other: No Clinical Follow up Other: Quality of Life questionnaire Other: Patient satisfaction Questionnaire Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction
Study Start Date : February 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Standard clinical intervention
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.
 Other: Quality of Life questionnaire
Other Name: VQOL

Other: Patient satisfaction Questionnaire
Conducted at Research clinic.
No Clinical Follow up
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.
 Other: No Clinical Follow up
Other: Quality of Life questionnaire
Other Name: VQOL

Other: Patient satisfaction Questionnaire
Conducted at Research clinic.


Outcome Measures
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Primary Outcome Measures :
  1. Corrected distance visual acuity (VA) [ Time Frame: 3 Months ]
  2. Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Post operative complication rate between the two groups [ Time Frame: 3 Months ]
  2. Post operative patient satisfaction between the two groups [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults Aged >= 40 years
  • Scheduled for day-case cataract surgery
  • Able to give informed consent

Exclusion Criteria:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02071147


Locations
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United Kingdom
Torbay District General Hospital Recruiting
Torquay, Devon, United Kingdom, TQ2 7AA
Contact: Fiona Roberts, PhD    +44 (0) 1803 656635    fiona.roberts@nhs.net   
Contact: Manger Of Research and Development    +44 (0) 1803 656635    sdhct.research@nhs.net   
Principal Investigator: Andrew Frost, MBChB, MRCP, FRCOphth, PhD         
Sponsors and Collaborators
Torbay and South Devon NHS Foundation Trust
Investigators
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Principal Investigator: Andrew Frost, MBchB, MRCP, FRCOphth, PHD Torbay and South Devon NHS Foundation Trust
More Information
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Responsible Party: Torbay and South Devon NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02071147    
Other Study ID Numbers: 14/02/050
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Keywords provided by Torbay and South Devon NHS Foundation Trust:
Follow-up
No follow-up
removal
Randomised Controlled Trial
6 Weeks
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases