NCT01165801

Brief Summary

The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

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

January 1, 2002

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

5.7 years

First QC Date

July 17, 2010

Last Update Submit

July 19, 2010

Conditions

Age-Related Macular Degeneration

Keywords

AMDCataract surgerySize of AMDInfluence of cataract surgery on AMD Size

Outcome Measures

Primary Outcomes (1)

  • AMD size (defined central region of interest)

    To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.

    at enrollment, after 6 months

Secondary Outcomes (1)

  • Functional ophthalmic assessments

    at enrollment, after 6 months

Study Arms (1)

Control Group (CO)

NO INTERVENTION

Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.

Procedure: Cataract Surgery

Interventions

Cataract SurgeryPROCEDURE

Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.

Control Group (CO)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cataract and non-exudative age-related macular degeneration

You may not qualify if:

  • Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia \> 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rudolph Foundation Hospital, Dept. of Ophthalmology

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2010

First Posted

July 20, 2010

Study Start

January 1, 2002

Primary Completion

September 1, 2007

Study Completion

July 1, 2010

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

AU(1)