Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06194760
• Other study ID #: Vitrectomy with ILM peeling
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: December 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: January 15, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
• Macular hole and only posterior retinal detachment

Exclusion Criteria:

• Other causes of RD
• Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
• History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• Vitrectomy with ILM peeling
Vitrectomy with traditional internal limiting membrane (ILM) peeling technique is regarded as the gold standard treatment for MH; it works by completely relieving of the traction of the macula and increasing the flexibility of the retina

Locations

Country	Name	City	State
Egypt	Ehab tharwat	Damieta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of macular hole	It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination	6 months post operative
Primary	BCVA	It is a measure of the visual acuity, which will be measured by LogMar	baseline
Primary	BCVA	It is a measure of the visual acuity, which will be measured by LogMar	6 months postoperative
Primary	BCVA	It is a measure of the visual acuity, which will be measured by LogMar	12 months postoperative