Macular Holes
Conditions
Keywords
Macular Holes, Non face down positioning, Face down positioning
Brief summary
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial. Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.
Interventions
PROCEDUREVitrectomy & Intraocular gas fill
PROCEDUREPostoperative face-down positioning
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic macular hole stage II-IV * Informed consent * Duration of symptoms ≤ 24 months
Exclusion criteria
* Previous vitreomacular surgery * Myopia ≥ 8 diopters * Ocular trauma * Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure rate | 3 months | Macular hole closure rate assessed by optical coherence tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETDRS Visual Acuity Gain | 3 months | — |
| Degree of postoperative head incline | 3 days | Position Sensor |
| Degree of ocular gas fill | 4 days | — |
Other
| Measure | Time frame |
|---|---|
| Frequency of the complications | During 3 months |
Countries
Denmark
Outcome results
None listed