Surgical therapy of idiopathic macular hole with The Inverted Flap Technique: a morphological and functional analysis

• Conditions: Primary idiopathic macular hole

• Registration Number: DRKS00021241
• Lead Sponsor: Augenzentrum Nymphenburger Höfe Augenklinik Herzog Carl Theodor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Diagnosis of a primary penetrating macular hole treated by pars plana vitrectomy and inverted lamina-limitans-interna flap.

Exclusion Criteria

Patients under 18 years of age; the presence of other severe retinal pathologies besides macular hole, e.g. proliferative diabetic retinopathy, retinal dystrophies or severe bulbar trauma; macular drusen were not a criterion for exclusion. Macular holes of secondary or traumatic etiology as well as refractory macular holes, i.e. those that had not been operated on before, were not included in the study; preoperative intravitreal application of Ocriplasmin was not a criterion for exclusion; patients who had not been documented by OCT were not included in the study.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the postoperative hole closure rate. Hole closure is defined as continuity of the foveal retinal layers detectable by optical coherence tomography without the presence of a vertical full-thickness defect. Hole closure rate is the number of macular holes closed after surgery divided by the number of eyes operated on.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints were defined as best corrected visual acuity, presence of metamorphopsia in the Amsler grid and macular morphology according to optical coherence tomography findings. <br><br>The description of macular morphology is evaluated by measuring the macular hole size, determining the postoperative central foveal thickness and the central photoreceptor layer thickness, and by classification of hole closure types and analysis of the structure of retinal layers.