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Prophylactic Laser Treatment of Drusen Maculopathy

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

laser treatment

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring age-related macula degeneration, prophylactic laser treatment, exudative complication

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept of Ophthalmology, Linköping University

Outcomes

Primary Outcome Measures

Change in visual acuity

Secondary Outcome Measures

incidence of exudative complications

Full Information

NCT ID

NCT00348543

First Posted

July 3, 2006

Last Updated

August 3, 2011

Sponsor

University Hospital, Linkoeping

1. Study Identification

Unique Protocol Identification Number

NCT00348543

Brief Title

Prophylactic Laser Treatment of Drusen Maculopathy

Official Title

Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.

Study Type

Interventional

2. Study Status

Record Verification Date

October 1999

Overall Recruitment Status

Completed

Study Start Date

December 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Linkoeping

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

age-related macula degeneration, prophylactic laser treatment, exudative complication

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

laser treatment

Primary Outcome Measure Information:

Title

Change in visual acuity

Secondary Outcome Measure Information:

Title

incidence of exudative complications

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina I Frennesson, MD, PhD

Organizational Affiliation

Linkoeping University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Ophthalmology, Linköping University

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Laser Treatment of Drusen Maculopathy

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