Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

Study Overview
=================
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.

Official Title
-----------------
Measurement and Logging of Posturing Adherence of Patients After Intraocular Surgery With Gasendotamponades Using a Sensorsystem With Different Feedback-Methods

Conditions
-----------------
Retina; Lesion, Adherence

Intervention / Treatment
-----------------
* Device: Positioning measurement
* Device: Patient feedback
* Procedure: Usefulness of a sketch
* Device: Closure rate of macular holes


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With macular hole<br>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<br>* Logging of posturing informations<br>Device: Patient feedback<br>* Evaluation of patients questionary<br>Procedure: Usefulness of a sketch<br>* Helping the patients to understand posturing positions by randomized allocation of sketches<br>Device: Closure rate of macular holes<br>* closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=<br>|
| Experimental: Without macular hole<br>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<br>* Logging of posturing informations<br>Device: Patient feedback<br>* Evaluation of patients questionary<br>Procedure: Usefulness of a sketch<br>* Helping the patients to understand posturing positions by randomized allocation of sketches<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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. | up to 12 month |