NCT04676217

Brief Summary

Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

November 27, 2020

Last Update Submit

November 20, 2023

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (4)

  • Macular hole mid diameter

    Micrometer

    1 day

  • Macular hole basal diameter

    Micrometer

    1 day

  • Macular hole mid area

    Square micrometer

    1 day

  • Central retinal thickness

    Micrometer

    1 day

Study Arms (2)

FDP

ACTIVE COMPARATOR

Face down positioning

Procedure: Postoperative positioning advice

NSP

EXPERIMENTAL

No positioning named "non-supine positioning". Participants are to avoid recumbent positioning.

Procedure: Postoperative positioning advice

Interventions

Postoperative positioning advicePROCEDURE

The postoperative positioning advice until 3 am the same day.

FDPNSP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary macular hole
  • Able to sign informed consent
  • Signed informed consent

You may not qualify if:

  • Previous vitreoretinal surgery in the study eye
  • Secondary macular holes caused by other conditions than vitreomacular traction
  • Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
  • Posttraumatic macular hole
  • Macular holes secondary to retinal detachment or other retinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 19, 2020

Study Start

January 1, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)