Prophylactic Laser Treatment of Drusen Maculopathy

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348543
• Other study ID #: Dnr 97346
• Status: Completed
• Phase: N/A
• First received: July 3, 2006
• Last updated: August 3, 2011
• Start date: December 1999
• Est. completion date: October 2006

Study information

• Verified date: October 1999
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Linköping University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• laser treatment

Locations

Country	Name	City	State
Sweden	Dept of Ophthalmology, Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity
Secondary	incidence of exudative complications