Evaluation of Posturing-Adherence in Patients After Intraocular Surgery
Measurement and Logging of Posturing Adherence of Patients After Intraocular Surgery With Gasendotamponades Using a Sensorsystem With Different Feedback-Methods
1 other identifier
interventional
48
1 country
1
Brief Summary
Measuring and logging head positions of patients which underwent surgery with gasendotamponades.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
1 active site
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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 19, 2016
July 1, 2016
1.5 years
December 8, 2014
July 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Effective time of ideal posturing with different sensors-systems
Time (measured in minutes and in percent of 24h) with correct posturing in relation to the used sensor-type (with and without feedback)
up to 12 month
Secondary Outcomes (4)
Time analysis with optimal posturing after detailed explanation of posturing positions
up to 12 month
Analysis of time with optimal posturing for both Sensor-Feedback-Systems
up to 12 month
Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)
up to 12 month
Tolerability of sensor-systems for patients as measured by questionnaire
up to 12 month
Study Arms (2)
With macular hole
EXPERIMENTALInclusion of patients with macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch Closure rate of macular holes
Without macular hole
EXPERIMENTALInclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch
Interventions
Helping the patients to understand posturing positions by randomized allocation of sketches
closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=
Eligibility Criteria
You may qualify if:
- age \>18 years
- full thickness macular hole or retinal detachment
- informed consent
You may not qualify if:
- intraoperative complications with the need of other endotamponades
- combined treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Eye Hospital
Tübingen, Baden-Wurttemberg, 72076, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
January 13, 2015
Study Start
October 1, 2014
Primary Completion
April 1, 2016
Study Completion
July 1, 2016
Last Updated
July 19, 2016
Record last verified: 2016-07