Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAin Shams University

About this trial

The aim of this study is to compare the functional visual outcomes, anatomical closure rate and macular perfusion changes assessed by OCT and OCTA after surgical repair of macular hole using Tenon capsule graft versus ILM flap.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with idiopathic full-thickness macular hole

≥400 µm in horizontal diameter

Disqualifiers

Media opacity preventing adequate OCT/OCTA imaging

Other retinal vascular pathology as retinal vascular occlusion

Intraoperative complications

Signal noise ratio using OCTA <6\10

Trial design

Design model

Parallel

Treatments tested in this trial

  • vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]

    Procedure/Surgery

    Prospective interventional study In all patients (Group A \& B), PPV will be performed using a 23-gauge, transconjunctival, microincision vitrectomy system. Diluted triamcinolone acetonide (40 mg/ml) will be used to visualize the vitreous. After core vitrectomy, posterior hyaloid detachment will be attempted with the vitrectomy cutter in the suction mode. Then, the ILM will be stained using 0.05% Brilliant Blue G (OCUBLUE PLUS, India). In Group A: tenon capsule graft will be attempted In Group B: free flap ILM peeling will be attempted SF6 gas will be used as tamponade in both groups More than one vitreoretinal surgeon will participate

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ILM flapOther 1 intervention
Group B: Tenon capsule graftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

-Improvement in best corrected visual acuity (BCVA)

Improvement in BCVA measured by snellen E chart then transformation to Logarithm of the minimum angle of resolution (Log MAR)

Time frame
3 months postoperative

Secondary outcomes

1

OCT

To assess healing and closure of hole by OCT OptovueInc, Fremont, CA (qualitative measure to assess if the hole is closed or not)

Time frame
3 months postoperative
2

OCTA

superficial and deep capillary plexuses vessel density assessment by OCTA OptovueInc, Fremont, CA Sequential optical coherence tomography scans of a specific retinal region will be performed (central 3x3 Macular area Superficial, deep capillary plexus and choriocapillaris) and images will be processed in order to obtain motion contrast of erythrocytes within the vessel, thereby providing detailed imaging of the retinal capillary network. Capillary plexus density (CPD) of vessels in SCP, DCP and the size of the FAZ will be detected by OCTA en-face images. (Density is measured as percentage and thickness is measured by micrometer )

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.