Prophylactic Laser Treatment of Drusen Maculopathy | NCT00348543

Studies
Prophylactic Laser Treatment of Drusen Maculopathy

NCT00348543

Sponsor

University Hospital, Linkoeping

Status

Completed

Last Update Posted

Aug 5, 2011Estimated

Enrollment

150

Phase

Not Applicable

Conditions

Age-related Macular Degeneration

Interventions

laser treatment

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 1999

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1999

Primary Completion Date

Not provided

Completion Date

Oct 2006Actual

First Submitted Date

Jul 3, 2006

First Submission Date that Met QC Criteria

Jul 3, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2011

Last Update Posted Date

Aug 5, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
laser treatment	Procedure

Measure	Description	Time Frame
Change in visual acuity

Measure	Description	Time Frame
incidence of exudative complications

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina I Frennesson, MD, PhD	Linkoeping University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Ophthalmology, Linköping University		Linköping		SE-581 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided