Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

NCT ID: NCT01383772

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to determine the risk of failing the visual field criteria to hold a driving license following retinal laser treatment delivered with a multi-spot photocoagulator.

Detailed Description

Despite improvements in the management of diabetes, the incidence of severe diabetes -related eye disease remains high. Laser treatment (panretinal photocoagulation (PRP)) is the gold standard treatment for reducing the risk of visual loss. However, evidence suggests that PRP can be damaging on visual field function and thus jeopardize patients' eligibility to drive. In the UK, it is the patient's responsibility to inform the DVLA that they are receiving retinal laser.

With the use of a multi-spot Photocoagulator for application of PRP at Moorfields the investigators are in a unique position to assess the effects of laser applied with this new delivery system on visual fields in a detailed fashion. Thus providing more accurate advice on visual prognosis and visual field function and addressing the risk of losing the ability to drive.

All treatment-naive patients with severe diabetic retinopathy requiring bilateral retinal laser treatment will be identified. Following informed consent these patients will undergo baseline visual field testing which will be of a duration of approximately 30 minutes and complete a quality of life questionnaire. All patients will receive their laser treatment as part of standard clinical care via the multi-spot Photocoagulator which will require approximately four 20 minute sessions. At 6 months following the completion of treatment the patients will undergo repeat visual field testing as conducted at baseline and complete a quality of life questionnaire. The investigators hope to recruit 100 patients.

Analysis of visual fields will principally involve assessment of whether patients have met the UK driving standards on Estermann VF testing. A quantitative assessment of change in retinal sensitivity will be undertaken by comparing retinal sensitivity pre and post-PRP.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Visual fields

One arm study. All patients will receive laser treatment following visual field testing.

Group Type: EXPERIMENTAL

Pan retinal Photocoagulation

Intervention Type: PROCEDURE

All patients with bilateral proliferative diabetic retinopathy requiring bilateral pan retinal photocoagulation will undergo baseline visual field tests prior to commencing laser treatment. These fields will be repeated at 6 months following completion of laser treatment.

Interventions

Pan retinal Photocoagulation

All patients with bilateral proliferative diabetic retinopathy requiring bilateral pan retinal photocoagulation will undergo baseline visual field tests prior to commencing laser treatment. These fields will be repeated at 6 months following completion of laser treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients of either sex aged 18 years or over.
• Diabetes mellitus (type 1 or type 2).
• Best corrected visual acuity (BCVA) > or equal 6/60 in both eyes.
• Requiring full bilateral PRP.
• No previous laser treatment.
• Subject cooperation sufficient for adequate visual field testing.
• Ability to return for regular study visits.

Exclusion Criteria

• Co-existent ocular/systemic condition that may affect visual field.
• Visual acuity less than 6/60 that may affect accuracy of visual field test.
• Presence of vitreous haemorrhage.
• Intraocular surgery/other intervention anticipated in either eye during the duration of treatment and VF assessment.
• Previous PRP.
• Age below 18.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insulin Dependant Diabetes Trust

UNKNOWN

Sponsor Role: collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Michel Michaelides

Consultant and Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Michaelides, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

Moorfields Eye Hospital NHS Foundation Trust

Locations

Moorfields Eye Hospital

London, London, United Kingdom

Countries

United Kingdom

Other Identifiers

MICM1005

Identifier Type: -

Identifier Source: org_study_id