Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

NCT01383772 | Completed DMC

• 1 other identifier: MICM1005
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative diabetic retinopathy; Pan retinal photocoagulation; Multi-spot Photocoagulator; Visual field tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual field assessment prior to planned pan retinal photocoagulation

  at baseline

Study Arms (1)

Visual fields

EXPERIMENTAL

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

Procedure: Pan retinal Photocoagulation

Interventions

Pan retinal Photocoagulation 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.

Visual fields

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Insulin Dependant Diabetes Trust: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, London, EC1V2PD, United Kingdom

Location

Study Officials

• Michel Michaelides, FRCOphth

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Professor of Ophthalmology

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

GB (1)