NCT00348543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 5, 2011

Status Verified

October 1, 1999

First QC Date

July 3, 2006

Last Update Submit

August 3, 2011

Conditions

Age-related Macular Degeneration

Keywords

age-related macula degenerationprophylactic laser treatmentexudative complication

Outcome Measures

Primary Outcomes (1)

  • Change in visual acuity

Secondary Outcomes (1)

  • incidence of exudative complications

Interventions

laser treatmentPROCEDURE

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Ophthalmology, Linköping University

Linköping, SE-581 85, Sweden

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Christina I Frennesson, MD, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 4, 2006

Study Start

December 1, 1999

Study Completion

October 1, 2006

Last Updated

August 5, 2011

Record last verified: 1999-10

Locations

SE(1)