Clinical trial NCT03020459: Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes
Official title: Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole
Surgery
Keywords: macular holes
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected visual acuity(BCVA)
timeFrame: Pre-operation and 6 months after operation
Secondary outcomes:
measure: Close rate of macular holes
timeFrame: 1 month after operation
Other outcomes:
measure: Morphologic changes of inner retina
timeFrame: 1，3，6 months after operation
measure: Central retinal thickness change
timeFrame: Pre-operation and 1，3，6 months after operation
measure: Mean foveal light sensitivity change
timeFrame: Pre-operation and 1，3，6 months after operation
measure: Fixation stability change
timeFrame: Pre-operation and 1，3，6 months after operation
measure: Multifocal electroretinogram(Mf-ERG) change
timeFrame: pre-operation and 1，3，6 months after operation
measure: M-chart score change
timeFrame: Pre-operation and 1，3，6 months after operation
measure: Visual function questionnaire-25(VFQ-25) score change
timeFrame: Pre-operation and 1，3，6 months after operation
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
name: Peiquan Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: