Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020459
• Other study ID #: XH-16-049
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: February 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations
• Surgery

Intervention

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.
• 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.

Drug:
• Brilliant Blue G
We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.

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).

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morphologic changes of inner retina	Dimpling observed from optical coherence tomography	1,3,6 months after operation
Other	Central retinal thickness change	Measured by software in optical coherence tomography	Pre-operation and 1,3,6 months after operation
Other	Mean foveal light sensitivity change	Measured by microperimetry	Pre-operation and 1,3,6 months after operation
Other	Fixation stability change	Measured by microperimetry	Pre-operation and 1,3,6 months after operation
Other	Multifocal electroretinogram(Mf-ERG) change	An objective measurement of retinal functions	pre-operation and 1,3,6 months after operation
Other	M-chart score change	M-horizontal score and M-vertical score	Pre-operation and 1,3,6 months after operation
Other	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
Primary	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	Close rate of macular holes	Observed from optical coherence tomography	1 month after operation