Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

Not Applicable

Completed

• Conditions: Retina; Lesion; Adherence
• Interventions: Device: Positioning measurement; Device: Patient feedback; Procedure: Usefulness of a sketch; Device: Closure rate of macular holes

• Registration Number: NCT02336334
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2016-04
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without macular hole	Positioning measurement	Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch
With macular hole	Positioning measurement	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
With macular hole	Closure rate of macular holes	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
Without macular hole	Usefulness of a sketch	Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch
With macular hole	Usefulness of a sketch	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
With macular hole	Patient feedback	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
Without macular hole	Patient feedback	Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)
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.
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

Trial Locations

Locations (1)

University Eye Hospital; 🇩🇪 Tuebingen, BW, Germany