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

October 25, 2023 updated by: Peiquan Zhao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200000
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Translocation
Procedure: Translocation ILM Flap
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.
Active Comparator: Peeling
Procedure: ILM Peeling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
The best corrected visual acuity indicates the best visual acuity with proper refractive correction.
1 week, 1 month, 3 months, 1 years, 2 years after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Closure rate
Time Frame: 1 week, 1 month, 3 months, 1 years, 2 years after the operation
MH closure is mainly reflected in the outer layer of continuity closure shown on OCT.
1 week, 1 month, 3 months, 1 years, 2 years after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Municipal Science and Technology Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Peiquan Zhao, Dr., Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XH-22-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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