search
Back to results

Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

Primary Purpose

Macular Holes

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Translocation ILM Flap
ILM Peeling
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 Holes

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time. Participants diagnosed with idiopathic macular hole (IMH). Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm. Participants with an axial length <26.0mm and a myopic degree lower than 6D. For participants with bilateral macular holes, the eye with a larger hole diameter will be included. Exclusion Criteria: Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment; Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D); Patients with a history of ocular trauma or retinal laser treatment; Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia; Patients with contraindications to vitrectomy; Patients with severe or unstable systemic diseases; Patients with a fasting blood glucose level ≥ 9mmol/L before surgery; Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening; Patients with a history of intraocular surgery within 3 months prior to screening; Patients with reduced visual function or vision in the contralateral eye as determined by the investigator; Patients who are not considered suitable for enrollment by the investigator for other reasons.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Translocation

Peeling

Arm Description

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity

Secondary Outcome Measures

MH closure rate

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Municipal Science and Technology Commission
search

1. Study Identification

Unique Protocol Identification Number
NCT06063005
Brief Title
Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
Official Title
Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Municipal Science and Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main objective of this study is to evaluate the therapeutic effectiveness of the internal limiting membrane (ILM) peeling and translocation surgery compared to the conventional surgical approach for treating large idiopathic macular hole (IMH) through a well-designed prospective randomized controlled clinical trial. This study aims to compare the new surgical approach to the conventional approach in terms of improving visual function, promoting macular retinal anatomical healing, and enhancing patients' quality of life. By conducting this prospective clinical trial, establishing a database, and generating clinical reports and evidence-based medicine on the therapeutic efficacy of the ILM peeling and translocation surgery for large IMH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Translocation
Arm Type
Experimental
Arm Title
Peeling
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Translocation ILM Flap
Intervention Description
After vitrectomy, the ILM was dissected from the macula to the vascular arch, and the retina in the fissure area was fully released to make an MH-centered, approximately 2DD-square, ILM flap with a tip (approximately 500μm wide) above; the ILM flap was transposed approximately 25-30 degrees along the tip to the inferior temporal area with the assistance of heavy water, and a total of 1ml of perfluorodecalin fluid (heavy water) was injected to cover the MH area with the ILM flap, and the original ILM defect area corresponding to the MH was transposed to the outside of the MH. The heavy water is replaced by liquid/gas exchange. Ophthalmic 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen as the postoperative intraocular filling.
Intervention Type
Procedure
Intervention Name(s)
ILM Peeling
Intervention Description
After vitrectomy, internal limiting membrane peeling up to the vascular arcade, thorough loosening of the macular hole area of the retina, and fluid/gas exchange. An eye-specific 13% perfluoropropane gas (AL.CHI.MI.A. Srl) was chosen for intraocular tamponade after the operation.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
1 week, 1 month, 3 months, 1 years, 2 years after the operation
Secondary Outcome Measure Information:
Title
MH closure rate
Time Frame
1 week, 1 month, 3 months, 1 years, 2 years after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who can understand the purpose of this clinical trial, volunteer to participate, sign an informed consent form, and can complete the postoperative follow-up on time. Participants diagnosed with idiopathic macular hole (IMH). Based on OCT scans, the minimum horizontal diameter of the macular hole is >500 and <900 µm. Participants with an axial length <26.0mm and a myopic degree lower than 6D. For participants with bilateral macular holes, the eye with a larger hole diameter will be included. Exclusion Criteria: Patients with the following retinal disorders: age-related macular degeneration, epi-macular membrane neovascularization, non-macular retinal tears, lesions of the retinal pigment epithelium and choroid, inherited or degenerative retinal diseases, optic neuropathies, retinal vascular diseases; patients with large macular holes accompanied by retinal detachment; Patients with high myopia (axial length ≥ 26.0mm and myopia exceeding 6D); Patients with a history of ocular trauma or retinal laser treatment; Patients with glaucoma, ocular infections, inflammations, tumors, corneal diseases, or amblyopia; Patients with contraindications to vitrectomy; Patients with severe or unstable systemic diseases; Patients with a fasting blood glucose level ≥ 9mmol/L before surgery; Patients who participated in other clinical trials involving drugs or medical devices within 30 days prior to screening; Patients with a history of intraocular surgery within 3 months prior to screening; Patients with reduced visual function or vision in the contralateral eye as determined by the investigator; Patients who are not considered suitable for enrollment by the investigator for other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiquan Zhao, Dr.
Phone
0086 13311620396
Email
zhaopeiquan@xinhuamed.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiao Lyu, Dr.
Phone
0086 13564910954
Email
cherryfcl@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiquan Zhao, Dr.
Organizational Affiliation
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiquan Zhao, Ph.D.
Phone
+86 13311620396
Email
zhaopeiquan@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Translocated Internal Limiting Membrane Flap Reposition for the Treatment of Idiopathic Macular Hole

We'll reach out to this number within 24 hrs