Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

July 18, 2016 updated by: University Hospital Tuebingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With macular hole

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
Logging of posturing informations
Device: 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=
Experimental: Without macular hole

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
Logging of posturing informations
Device: Patient feedback
Evaluation of patients questionary
Procedure: Usefulness of a sketch
Helping the patients to understand posturing positions by randomized allocation of sketches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective time of ideal posturing with different sensors-systems
Time Frame: 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)
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 Frame: 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)
up to 12 month
Analysis of time with optimal posturing for both Sensor-Feedback-Systems
Time Frame: 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)
up to 12 month
Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)
Time Frame: 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
up to 12 month
Tolerability of sensor-systems for patients as measured by questionnaire
Time Frame: up to 12 month
Using a questionnaire patients are asked to give their view on the tolerability of the used system.
up to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PosturingSensor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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