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Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

Primary Purpose

Macular Hole, Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
peeling-reposition
peeling
Brilliant Blue G
postoperative posture
Constellation 23-gauge vitrectomy system
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole focused on measuring macular holes

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

peeling-reposition

peeling

Arm 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.

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.

Outcomes

Primary Outcome Measures

Best corrected visual acuity(BCVA)
Change from baseline BCVA at 6 months after operation, examined with snellen chart.

Secondary Outcome Measures

Close rate of macular holes
Observed from optical coherence tomography

Full Information

First Posted
January 11, 2017
Last Updated
May 11, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03020459
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole, Surgery
Keywords
macular holes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
peeling-reposition
Arm Type
Experimental
Arm 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.
Arm Title
peeling
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
peeling-reposition
Intervention Description
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
Intervention Name(s)
peeling
Intervention Description
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
Drug
Intervention Name(s)
Brilliant Blue G
Other Intervention Name(s)
BBG
Intervention Description
We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.
Intervention Type
Other
Intervention Name(s)
postoperative posture
Intervention Description
Patients of both two groups need to keep prone position for two weeks after the operation.
Intervention Type
Device
Intervention Name(s)
Constellation 23-gauge vitrectomy system
Intervention Description
All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).
Primary Outcome Measure Information:
Title
Best corrected visual acuity(BCVA)
Description
Change from baseline BCVA at 6 months after operation, examined with snellen chart.
Time Frame
Pre-operation and 6 months after operation
Secondary Outcome Measure Information:
Title
Close rate of macular holes
Description
Observed from optical coherence tomography
Time Frame
1 month after operation
Other Pre-specified Outcome Measures:
Title
Morphologic changes of inner retina
Description
Dimpling observed from optical coherence tomography
Time Frame
1,3,6 months after operation
Title
Central retinal thickness change
Description
Measured by software in optical coherence tomography
Time Frame
Pre-operation and 1,3,6 months after operation
Title
Mean foveal light sensitivity change
Description
Measured by microperimetry
Time Frame
Pre-operation and 1,3,6 months after operation
Title
Fixation stability change
Description
Measured by microperimetry
Time Frame
Pre-operation and 1,3,6 months after operation
Title
Multifocal electroretinogram(Mf-ERG) change
Description
An objective measurement of retinal functions
Time Frame
pre-operation and 1,3,6 months after operation
Title
M-chart score change
Description
M-horizontal score and M-vertical score
Time Frame
Pre-operation and 1,3,6 months after operation
Title
Visual function questionnaire-25(VFQ-25) score change
Description
A questionnaire consisted of 25 visual function questions concerning life quality
Time Frame
Pre-operation and 1,3,6 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiquan Zhao, PhD
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

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