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โ† Trials
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Full Thickness Macular Hole; Should it be Handled Subacutely?

RecruitingNAAges 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
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In plain words

What the trial is, and whether it could suit you

Full thickness macular hole, FTMH, is a retinal disease involving the fovea that cause central vision loss, metamorphopsia and central scotoma. The most effective treatment for FTMH is a pars plana vitrectomy and a tamponade with expansile gas. It is well known that vitrectomy accelerates cataract development. Vitrectomy can therefore be combined with cataract surgery in the same setting, a procedure that is shown to be safe, although increased inflammation and rates of central macular edema have been reported in some studies. Cataract surgery can also be performed prior or deferred until compromising the visual acuity after vitrectomy. Cataract-surgeries are more challenging in vitrectomized eyes due to lack of vitreous support and risk of loose zonules. The normal practice for FTMH at our department is therefore cataract surgery followed by vitrectomy 4 weeks later. A combined phaco-vi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Idiopathic full thickness macular hole * Duration of symptoms of \<30 days for Group 1 and 2 * Duration of symptoms of 3-12 months for Group 3 * FTMH size \<400ยตm * \>18 years * Able to give informed consent * Compliance for postoperative positioning Exclusion Criteria: * High myopia (โ‰ค-3) * Traumatic macular hole * Prior ocular surgery, including cataract surgery * Other ocular diseases compromising the visual acuity (i.e., AMD, diabetic retinopathy, previous vein occlusion) * Posterior vitreous detachment (Weiss ring)
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What it tests

  • Vitrectomy (Sequential phakoemulsification and vitrectomy)
  • Combined phako-vitrectomy
  • Phako (Sequential phakoemulsification and vitrectomy)
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Where

1 site
Rigshospitalet, Denmark
Glostrup Municipality, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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