Supine Positioning for Graft Attachment After Descemet Membrane Endothelial Keratoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-05-23

Brief Summary

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This randomized controlled trial evaluates the efficacy and safety of postoperative supine head positioning on graft attachment after Descemet membrane endothelial keratoplasty in patients with Fuchs' endothelial corneal dystrophy (FECD).

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Detailed Description

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In Descemet membrane endothelial keratoplasty (DMEK), an air or gas bubble is inserted in the anterior chamber of the eye to keep the ultrathin endothelial corneal graft attached to the patients own cornea. Supine positioning is thought to improve attachment by using the tamponade effect of the bubble. At present, it is unclear how long supine positioning is required. Positioning regimens vary between one hour to over one week. In this trial, the investigators will assess if prolonged supine positioning for 5 days improves graft attachment and long-term outcomes compared to supine positioning for 1 day.

Conditions

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Fuchs' Endothelial Dystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stratification will be performed according to the surgical procedure (DMEK alone or DMEK combined cataract surgery). Within each strata, participants will be randomized in a 1:1 ratio to 5 days (intervention) and 1 day (control) postoperative supine positioning.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants, care providers, surgeons, and investigators will be masked until the first postoperative day after DMEK. Investigators will open the opaque envelope with the study assignment together with the participant and inform care providers on the positioning regimen for the next 4 days.

The primary outcome will be assessed by a masked investigator using a trained and validated neural network for image segmentation.

Study Groups

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5 days supine positioning

Supine positioning for 5 days after DMEK with upright positioning for only 10 min every hour.

Group Type EXPERIMENTAL

Supine positioning: 5 days

Intervention Type BEHAVIORAL

Supine positioning for 5 days after DMEK

1 day supine positioning followed by usual physical activity for 4 days

Supine positioning for 1 days after DMEK with upright positioning for only 10 min every hour.

Group Type ACTIVE_COMPARATOR

Supine positioning: 1 days

Intervention Type BEHAVIORAL

Supine positioning for 1 days after DMEK

Interventions

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Supine positioning: 5 days

Supine positioning for 5 days after DMEK

Intervention Type BEHAVIORAL

Supine positioning: 1 days

Supine positioning for 1 days after DMEK

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)

Exclusion Criteria

* Other corneal diseases (i.e. corneal scars, corneal dystrophies except FECD, corneal inflammation / infection)
* Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, use of contact lenses in past four weeks, anesthetic eye drops)
* Diabetes mellitus with endorgan complications)
* Lack of fixation during corneal tomography
* Bedridden

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No