Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling

ILM Peeling Clinical Trial

Official title:

Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04312620
• Other study ID #: ILM peeling
• Status: Not yet recruiting
• Start date: April 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: almoatz bellah zohier mohamm,ed, master
• Phone: 01099490013
• Email: moatazmoh58[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evulate changes in VF and OCT after viterctomy associated with ILM peeling.

Description:

Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by fibrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myofibroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.

Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .

Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.

Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 8, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

1. 1-Idiopathic ERM,

2. Primary full thickness macular hole,

3. Lamellar macular hole, and

4. Vitromacular traction.

Exclusion Criteria:

• 1-Patients with a secondary ERM,

1. diabetic retinopathy,

2. venous occlusion,

3. retinal detachment,

4. uveitis, and

5. trauma. 2-Other ocular pathologies that could interfere with the functional results

1. dense cataract ,

2. glaucoma, and

3. previous retinal surgery.

Related Conditions & MeSH terms

• ILM Peeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Higashide T, Ohkubo S, Hangai M, Ito Y, Shimada N, Ohno-Matsui K, Terasaki H, Sugiyama K, Chew P, Li KK, Yoshimura N. Influence of Clinical Factors and Magnification Correction on Normal Thickness Profiles of Macular Retinal Layers Using Optical Coherence — View Citation

Noma H, Funatsu H, Sakata K, Harino S, Mimura T, Hori S. Macular microcirculation in hypertensive patients with and without branch retinal vein occlusion. Acta Ophthalmol. 2009 Sep;87(6):638-42. doi: 10.1111/j.1755-3768.2008.01318.x. Epub 2008 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	ILM peeling	6 months