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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04116892
Other study ID # IR001094
Secondary ID 2019-142
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date September 30, 2021

Study information

Verified date October 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Zhiyong Zhang, docter
Phone 13968059392
Email zhangziyongnet@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - idiopathic MHs, a minimum hole diameter of = 400 µm, and follow-up for at least 3 months after vitrectomy. Exclusion Criteria: - High myopia (=6 diopters,AL=26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
the Cover group
The internal limiting membrane around the MH was left to cover the hole
the Fill group
The internal limiting membrane around the MH was left to fill the hole
the peeling group
the internal limiting membrane was discarded

Locations

Country Name City State
China Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MH status MH status (open, flat open or closed) at 3 months after surgery
Primary IS/OS line interruption width IS/OS line interruption width were gauged with spectral-domain optical coherence tomography at 3 months after surgery
Primary Change from Baseline IS/OS line interruption width at 3 months IS/OS line interruption width were gauged with spectral-domain optical coherence tomography at 3 months after surgery
Primary 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 at 3 months after surgery
Primary 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 at 3 months after surgery
Primary visual function visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) at 3 months after surgery
Primary Change from Baseline visual function at 3 months visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) at 3 months after surgery
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