Foveal Sparing ILM Peeling With ILM Flap Transposition

Full Thickness Macular Hole Clinical Trial

Official title:

Foveal Sparing ILM Peeling With ILM Flap Transposition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897671
• Other study ID #: FSI
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Foveal sparing internal limiting membrane (ILM) peeling with ILM flap transposition over the macular hole combines the benefits of foveal sparing ILM peeling with ILM flap techniques.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

Description:

Idiopathic full thickness macular holes lead to central defects in the visual field and to deterioration of the visual acuity. Introduction of internal limiting membrane (ILM) Peeling techniques lead to significant increase in closure rates of the macular holes.

Foveal sparing ILM peeling represents a surgical technique for macular hole repair with less surgical trauma with high closure rates of the macular hole, compared to classic ILM Peeling [Ho et al. 2014, Murphy et al 2019]. The combination of foveal sparing ILM Peeling with the established ILM flap techniques [Michalewska et al 2010 und 2015] offers the potential of better improvement in postsurgical visual acuity with the high closure rates, due to ILM flaps.

Aim of this study is to retrospectively examine the rate of postsurgical macular hole closure, development of central atrophy in the foveal area, and improvement of best corrected distant visual acuity in a group of patients having undergone foveal sparing ILM peeling with ILM flap transposition for macular hole repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vitrectomy with foveal sparing ILM peeling with ILM flap transposition in the time period from 1.10.2020 to 8.7.2022

• Age 18 and older

• Idiopathic full thickness macular hole as indication for surgery

• Full follow-up, including visual acuity testing and OCT preoperative, and 3 months after surgery.

Exclusion Criteria:

• Age <18 years

Related Conditions & MeSH terms

• Full Thickness Macular Hole
• Retinal Perforations

Intervention

Other:
• retrospective data analysis
Macular hole closure rate, visual acuity and OCT

Locations

Country	Name	City	State
Austria	Hanusch Hospital, Department of Ophthalmology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macular hole closure rate	postsurgical closure of macular holes is examined from routine postsurgical optical coherence tomography (OCT) imaging	up to 3 months after surgery
Secondary	visual acuity	visual acuity before and 3 months after surgery is examined	3 months
Secondary	OCT	measurements of macular hole diameters from presurgical OCTs and restoration of the ellipsoid zone (EZ) 3 months after surgery is analysed	3 months