RCT of Follow up Following Cataract Extraction

NCT02071147 | Completed

• 1 other identifier: 14/02/050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Follow-up; No follow-up; removal; Randomised Controlled Trial; 6 Weeks

Outcome Measures

Primary Outcomes (2)

• Corrected distance visual acuity (VA)

  3 Months

• Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires

  3 Months

Secondary Outcomes (2)

• Post operative complication rate between the two groups

  3 Months

• Post operative patient satisfaction between the two groups

  3 months

Study Arms (2)

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.

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.

Other: No Clinical Follow up; Other: Quality of Life questionnaire; Other: Patient satisfaction Questionnaire

Interventions

No Clinical Follow up OTHER

No Clinical Follow up

Quality of Life questionnaire OTHER

Also known as: VQOL

No Clinical Follow up; Standard clinical intervention

Patient satisfaction Questionnaire OTHER

Conducted at Research clinic.

No Clinical Follow up; Standard clinical intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust: lead

Study Sites (1)

Torbay District General Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Andrew Frost, MBchB, MRCP, FRCOphth, PHD

  Torbay and South Devon NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: August 10, 2016
• Study Completion: August 10, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

GB (1)