An interventional study of Positioning measurement and Patient feedback in Retina; Lesion and Adherence, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-19.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment
Measuring and logging head positions of patients which underwent surgery with gasendotamponades.
After surgery with gasendotamponades various positions are recommended to support the success of surgery. In patients with macular holes face-down-position is recommended. In patients with retinal detachment the recommended position depends on the region of the detachment.
The adherence of patients to follow this posturing instructions is very inhomogenous. Therefore the investigators want to measure the posturing by the use of a position-sensor. In some study arms the patients also receive a feedback from the sensor (tone, vibration) to correct the position.
The sensor-device was developed by the study-staff and is not commercial available. In addition there is no trade name. The patients safety of the used device was approved by the in house technical department.
University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inclusion 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
Device: Positioning measurement · Device: Patient feedback · Procedure: Usefulness of a sketch · Device: Closure rate of macular holes
Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch
Device: Positioning measurement · Device: Patient feedback · Procedure: Usefulness of a sketch
Logging of posturing informations
Evaluation of patients questionary
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=
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)
Time frame: up to 12 month
Time analysis with optimal posturing after detailed explanation of posturing positions
Time (measured in minutes and in percent of 24h) with correct posturing in patients which received an detailed posturing explanation (with graphics)
Time frame: up to 12 month
Analysis of time with optimal posturing for both Sensor-Feedback-Systems
Time (measured in minutes and in percent of 24h) with correct posturing depending on the used sensor-type (noise vs. vibration)
Time frame: up to 12 month
Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)
Status of macular holes after 3 month in macular hole group measured by optical coherence tomography (hole closed: yes or no) and in relation to time with optimal posturing
Time frame: up to 12 month
Tolerability of sensor-systems for patients as measured by questionnaire
Using a questionnaire patients are asked to give their view on the tolerability of the used system.
Time frame: up to 12 month
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen