Retinal Laser by Multi-spot Photocoagulator and Driving Eligibility

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Moorfields Eye Hospital NHS Foundation Trust
Sponsor:
Collaborator:
Insulin Dependant Diabetes Trust
Information provided by (Responsible Party):
Michel Michaelides, Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01383772
First received: June 21, 2011
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Proliferative Diabetic Retinopathy
Procedure: Pan retinal Photocoagulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official 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

Resource links provided by NLM:


Further study details as provided by Moorfields Eye Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Risk of failing visual field criteria to hold a driving licence. [ Time Frame: visual fields at baseline and at 6 months. ] [ Designated as safety issue: No ]

    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:
  • Visual field assessment prior to planned pan retinal photocoagulation [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383772

Contacts
Contact: Michel Michaelides, FRCOphth 0207 608 6864 Michel.michaelides@ucl.ac.uk
Contact: Mala Subash, FRCOphth 02072533411 malavika.subash01@gmail.com

Locations
United Kingdom
Moorfields Eye Hospital Recruiting
London, United Kingdom, EC1V2PD
Contact: Michaelides       michel.michaelides@ucl.ac.uk   
Principal Investigator: Michel Michaelides, FRCOphth         
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Insulin Dependant Diabetes Trust
Investigators
Principal Investigator: Michel Michaelides, FRCOphth Moorfields Eye Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Michel Michaelides, Consultant and Senior Clinical Lecturer, Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01383772     History of Changes
Other Study ID Numbers: MICM1005
Study First Received: June 21, 2011
Last Updated: November 5, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
Proliferative diabetic retinopathy
Pan retinal photocoagulation
Multi-spot Photocoagulator
Visual field tests

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014