Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Surgery; Macular Hole
• Intervention / Treatment: Procedure: peeling-reposition; Drug: Brilliant Blue G; Other: postoperative posture; Device: Constellation 23-gauge vitrectomy system; Procedure: peeling

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: peeling-reposition; 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.	Procedure: peeling-reposition; After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The" ILM roll " was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively.; Drug: Brilliant Blue G; We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.; Other Names: BBG; Other: postoperative posture; Patients of both two groups need to keep prone position for two weeks after the operation.; Device: Constellation 23-gauge vitrectomy system; All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).
ACTIVE_COMPARATOR: peeling; 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.	Drug: Brilliant Blue G; We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.; Other Names: BBG; Other: postoperative posture; Patients of both two groups need to keep prone position for two weeks after the operation.; Device: Constellation 23-gauge vitrectomy system; All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).; Procedure: peeling; After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity(BCVA)	Change from baseline BCVA at 6 months after operation, examined with snellen chart.	Pre-operation and 6 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Close rate of macular holes	Observed from optical coherence tomography	1 month after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphologic changes of inner retina	Dimpling observed from optical coherence tomography	1，3，6 months after operation
Central retinal thickness change	Measured by software in optical coherence tomography	Pre-operation and 1，3，6 months after operation
Mean foveal light sensitivity change	Measured by microperimetry	Pre-operation and 1，3，6 months after operation
Fixation stability change	Measured by microperimetry	Pre-operation and 1，3，6 months after operation
Multifocal electroretinogram(Mf-ERG) change	An objective measurement of retinal functions	pre-operation and 1，3，6 months after operation
M-chart score change	M-horizontal score and M-vertical score	Pre-operation and 1，3，6 months after operation
Visual function questionnaire-25(VFQ-25) score change	A questionnaire consisted of 25 visual function questions concerning life quality	Pre-operation and 1，3，6 months after operation

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Peiquan Zhao, PhD, Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (ESTIMATE): January 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: macular holes
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: XH-16-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be shared after the end of this clinical trails.The data included patients' serial number, gender, age, laterality and all outcome measurement
• IPD Sharing Time Frame: After enrollment completed; After the last followup of the last participant.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No