RCT of Follow up Following Cataract Extraction

Cataract Clinical Trial

Official title:

Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071147
• Other study ID #: 14/02/050
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2014
• Last updated: May 18, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: South Devon Healthcare NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• No Clinical Follow up

• Quality of Life questionnaire

• Patient satisfaction Questionnaire
Conducted at Research clinic.

Locations

Country	Name	City	State
United Kingdom	Torbay District General Hospital	Torquay	Devon

Sponsors (1)

Lead Sponsor	Collaborator
South Devon Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected distance visual acuity (VA)		3 Months	No
Primary	Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires		3 Months	No
Secondary	Post operative complication rate between the two groups		3 Months	Yes
Secondary	Post operative patient satisfaction between the two groups		3 months	No