Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

NCT ID: NCT03020459

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-08-01

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.

Conditions

Macular Hole; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

peeling-reposition

Intervention Type: PROCEDURE

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.

Brilliant Blue G

Intervention Type: DRUG

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

postoperative posture

Intervention Type: OTHER

Patients of both two groups need to keep prone position for two weeks after the operation.

Constellation 23-gauge vitrectomy system

Intervention Type: DEVICE

All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).

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.

Group Type: ACTIVE_COMPARATOR

peeling

Intervention Type: PROCEDURE

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.

Brilliant Blue G

Intervention Type: DRUG

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

postoperative posture

Intervention Type: OTHER

Patients of both two groups need to keep prone position for two weeks after the operation.

Constellation 23-gauge vitrectomy system

Intervention Type: DEVICE

All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Brilliant Blue G

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

Intervention Type: DRUG

postoperative posture

Patients of both two groups need to keep prone position for two weeks after the operation.

Intervention Type: OTHER

Constellation 23-gauge vitrectomy system

All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).

Intervention Type: DEVICE

Other Intervention Names

BBG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peiquan Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Locations

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Countries

China

References

Tian T, Tan H, Zhu X, Zhang X, Zhao P. PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Pilot Randomized Controlled Trial. Retina. 2023 Feb 1;43(2):191-199. doi: 10.1097/IAE.0000000000003645. Epub 2022 Oct 8.

Reference Type: DERIVED

PMID: 36695790 (View on PubMed)

Other Identifiers

XH-16-049

Identifier Type: -

Identifier Source: org_study_id