Adherence, Retina; Lesion
Conditions
Brief summary
Measuring and logging head positions of patients which underwent surgery with gasendotamponades.
Detailed description
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.
Interventions
DEVICEPositioning measurement
Logging of posturing informations
DEVICEPatient feedback
Evaluation of patients questionary
PROCEDUREUsefulness of a sketch
Helping the patients to understand posturing positions by randomized allocation of sketches
DEVICEClosure rate of macular holes
closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * full thickness macular hole or retinal detachment * informed consent
Exclusion criteria
* intraoperative complications with the need of other endotamponades * combined treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective time of ideal posturing with different sensors-systems | up to 12 month | Time (measured in minutes and in percent of 24h) with correct posturing in relation to the used sensor-type (with and without feedback) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time analysis with optimal posturing after detailed explanation of posturing positions | up to 12 month | Time (measured in minutes and in percent of 24h) with correct posturing in patients which received an detailed posturing explanation (with graphics) |
| Analysis of time with optimal posturing for both Sensor-Feedback-Systems | up to 12 month | Time (measured in minutes and in percent of 24h) with correct posturing depending on the used sensor-type (noise vs. vibration) |
| Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no) | up to 12 month | 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 |
| Tolerability of sensor-systems for patients as measured by questionnaire | up to 12 month | Using a questionnaire patients are asked to give their view on the tolerability of the used system. |
Countries
Germany
Outcome results
None listed