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Completed

NCT Number: NCT02336334

Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

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

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Key information

Conditions

Retina; Lesion Adherence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positioning measurement

Device

Logging of posturing informations

Patient feedback

Device

Evaluation of patients questionary

Usefulness of a sketch

Procedure

Helping the patients to understand posturing positions by randomized allocation of sketches

Closure rate of macular holes

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2015
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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