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Completed

NCT Number: NCT01383772

Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Hospital

London, EC1V2PD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Risk of failing visual field criteria to hold a driving licence.

    Time frame: 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 outcomes

  1. Visual field assessment prior to planned pan retinal photocoagulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • Insulin Dependant Diabetes Trust

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2011
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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