Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

A Prospective Clinical Study of the Effects of Panretinal Photocoagulation Delivered With a Multi-spot Photocoagulator on Retinal Sensitivity and Driving Eligibility in Patients With Diabetic Retinopathy

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.

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Procedure: Pan retinal Photocoagulation

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V2PD
    • Moorfields Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual fields; One arm study. All patients will receive laser treatment following visual field testing.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of failing visual field criteria to hold a driving licence.	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.	visual fields at baseline and at 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual field assessment prior to planned pan retinal photocoagulation	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.	at baseline

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborators: Insulin Dependant Diabetes Trust
• Investigators: Principal Investigator: Michel Michaelides, FRCOphth, Moorfields Eye Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Proliferative diabetic retinopathy; Pan retinal photocoagulation; Multi-spot Photocoagulator; Visual field tests
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: MICM1005