Evaluation of Posturing-Adherence in Patients After Intraocular Surgery

University Hospital Tuebingen

Status: Completed

Conditions: Retina; Lesion; Adherence

Treatments: Device: Closure rate of macular holes; Device: Positioning measurement; Procedure: Usefulness of a sketch; Device: Patient feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02336334

PosturingSensor

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

With macular hole

Experimental group

Description:

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

Treatment:

Device: Patient feedback

Device: Positioning measurement

Device: Closure rate of macular holes

Procedure: Usefulness of a sketch

Without macular hole

Experimental group

Description:

Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types Interventions: Positioning measurement Patient feedback Usefulness of a sketch

Treatment:

Device: Patient feedback

Device: Positioning measurement

Procedure: Usefulness of a sketch