Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

Shanghai Jiao Tong University

Status: Completed

Conditions: Surgery; Macular Hole

Treatments: Drug: Brilliant Blue G; Other: postoperative posture; Procedure: peeling-reposition; Procedure: peeling; Device: Constellation 23-gauge vitrectomy system

Study type: Interventional

Funder types: Other

Identifiers

NCT03020459

XH-16-049

Details and patient eligibility

About

To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes

Full description

This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups.

Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up.

Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients are diagnosed as macular hole by optical coherence tomography.
• Age ranges from 50 to 80 years.
• The patients have indication for surgery.

Exclusion criteria

• Traumatic macular hole.
• Combined with serious epiretinal membrane.
• Combined with diabetic retinopathy, hypertensive retinopathy.
• Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
• • 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.
• History of intraocular surgery.
• Presence of staphyloma.
• Other ocular diseases that could influence macular microstructure or visual function

Exit criteria:

• For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.
• Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
• Drop out;
• The patients voluntarily withdraw the informed consent;
• Serious violation of the study protocol due to the subjects or investigators' reasons;
• Other reasons that the researchers believe for quitting the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

peeling-reposition

Experimental group

Description:

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of "peeling-reposition" was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation.

Treatment:

Device: Constellation 23-gauge vitrectomy system

Other: postoperative posture

Procedure: peeling-reposition

Drug: Brilliant Blue G

peeling

Active Comparator group

Description:

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of "peeling" was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation.

Treatment:

Device: Constellation 23-gauge vitrectomy system

Other: postoperative posture

Procedure: peeling

Drug: Brilliant Blue G