Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336334
• Other study ID #: PosturingSensor
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: July 18, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Measuring and logging head positions of patients which underwent surgery with gasendotamponades.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adherence
• Retina; Lesion

Intervention

Device:
• Positioning measurement
Logging of posturing informations
• Patient feedback
Evaluation of patients questionary

Procedure:
• Usefulness of a sketch
Helping the patients to understand posturing positions by randomized allocation of sketches

Device:
• Closure rate of macular holes
closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=

Locations

Country	Name	City	State
Germany	University Eye Hospital	Tuebingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No