Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

Not Applicable

Completed

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Procedure: Pan retinal Photocoagulation

• Registration Number: NCT01383772
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2012-06
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visual fields	Pan retinal Photocoagulation	One arm study. All patients will receive laser treatment following visual field testing.

Primary Outcome Measures

Name	Time	Method
Risk of failing visual field criteria to hold a driving licence.	visual fields at baseline and at 6 months.	All patients requiring bilateral PRP will be identified. These patients will undergo binocular and uniocular full-field static and kinetic visual field testing; All patients will receive their PRP via the multi-spot Photocoagulator using standardised parameters for treatment.; At 6 months following the completion of PRP the patients will undergo repeat visual field testing as conducted at baseline.; Analysis of visual fields will principally involve qualitative assessment of whether patients have met the UK driving standards on Estermann VF testing.

Secondary Outcome Measures

Name	Time	Method
Visual field assessment prior to planned pan retinal photocoagulation	at baseline	Evaluation of full-field retinal sensitivity with visual field tests in patients with severe pre-proliferative or proliferative DR prior to planned PRP.; A quantitative assessment of retinal sensitivity using the mean global retinal sensitivity and measuring the entire hill-of-vision.; This will also be addressed at 6 months following PRP to compare to pre- treatment values.

Trial Locations

Locations (1)

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom