An interventional study of the Cover group and the Fill group in Macular Holes, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.
Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.
156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 104 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
the internal limiting membrane was discarded
Procedure: the peeling group
the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.
Procedure: the Cover group
the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.
Procedure: the Fill group
The internal limiting membrane around the MH was left to cover the hole
The internal limiting membrane around the MH was left to fill the hole
the internal limiting membrane was discarded
MH status
MH status (open, flat open or closed)
Time frame: at 3 months after surgery
IS/OS line interruption width
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Time frame: at 3 months after surgery
Change from Baseline IS/OS line interruption width at 3 months
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Time frame: at 3 months after surgery
Baseline best-corrected visual acuity
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Time frame: at 3 months after surgery
Change from Baseline best-corrected visual acuity at 3 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Time frame: at 3 months after surgery
visual function
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Time frame: at 3 months after surgery
Change from Baseline visual function at 3 months
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Time frame: at 3 months after surgery
Plan to share: No
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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University