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Prophylactic Laser Treatment of Drusen Maculopathy

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ClinicalTrials.gov Identifier: NCT00348543
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
University Hospital, Linkoeping

Brief Summary:
To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Procedure: laser treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.
Study Start Date : December 1999
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in visual acuity

Secondary Outcome Measures :
  1. incidence of exudative complications


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 55 years of age,
  • Soft drusen maculopathy,
  • VA 0.8-1.0

Exclusion Criteria:

  • VA <0.8,
  • Pigment clumps,
  • PED,
  • CNV,
  • Atrophy,
  • Haemorrhage,
  • Diabetes retinopathy,
  • Sign cataract,
  • Glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348543


Locations
Sweden
Dept of Ophthalmology, Linköping University
Linköping, Sweden, SE-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Christina I Frennesson, MD, PhD Linkoeping University

ClinicalTrials.gov Identifier: NCT00348543     History of Changes
Other Study ID Numbers: Dnr 97346
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: October 1999

Keywords provided by University Hospital, Linkoeping:
age-related macula degeneration
prophylactic laser treatment
exudative complication

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases