NCT01945892

Brief Summary

To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

September 16, 2013

Last Update Submit

September 18, 2013

Conditions

Macular EdemaVisual Acuity

Keywords

macular edema, irvine gass syndrome, ozurdex

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Best corrected visual acuity and visual acuity gain after 6 and 12 months.

    12 months

Secondary Outcomes (2)

  • Retinal Thickness

    12 months

  • Intraocular pressure

    12 months

Study Arms (1)

Irvine Gass Syndrome

Patients older than 18 years who develop macula edema secondary to cataract surgery. Group may receive intravitreal Ozurdex medication in case of persistent macular edema.

Drug: Ozurdex

Interventions

OzurdexDRUG

\- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".

Also known as: Dexamethasone-implant
Irvine Gass Syndrome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients older than 18 years.

You may qualify if:

  • Patients older than 18 years who develop macula edema secondary to cataract surgery

You may not qualify if:

  • Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Ophthalmology, LMU Munich

Munich, 80336, Germany

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Wolfgang J Mayer, MD

    LMU Munich

    PRINCIPAL INVESTIGATOR

  • Christos Haritoglou, MD, PhD

    LMU Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

DE(1)