Comparative Analysis of Large Macular Hole Surgeries

Macular Holes Clinical Trial

— CAOLMHS  

Official title:

Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116892
• Other study ID #: IR001094
• Secondary ID: 2019-142
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

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