Comparative Analysis of Large Macular Hole Surgeries (CAOLMHS)

October 25, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries

This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.

Study Overview

Status

Status

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

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.

Detailed Description

Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.

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 (Anticipated)

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.
100

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 Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.

Exclusion Criteria:

  • High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

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.
Active Comparator: the peeling group
the internal limiting membrane was discarded
Procedure: the peeling group
the internal limiting membrane was discarded
Experimental: the Cover group
the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.
Procedure: the Cover group
The internal limiting membrane around the MH was left to cover the hole
Experimental: the Fill group
the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.
Procedure: the Fill group
The internal limiting membrane around the MH was left to fill the hole

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
MH status
Time Frame: at 3 months after surgery
MH status (open, flat open or closed)
at 3 months after surgery
IS/OS line interruption width
Time Frame: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
at 3 months after surgery
Change from Baseline IS/OS line interruption width at 3 months
Time Frame: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
at 3 months after surgery
Baseline best-corrected visual acuity
Time Frame: at 3 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
at 3 months after surgery
Change from Baseline best-corrected visual acuity at 3 months
Time Frame: at 3 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
at 3 months after surgery
visual function
Time Frame: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
at 3 months after surgery
Change from Baseline visual function at 3 months
Time Frame: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
at 3 months after surgery

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.
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.
  • Principal Investigator: Tao Jiang, Second Affiliated Hospital, School of Medicine, Zhejiang University

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.
May 1, 2019

Primary Completion (Anticipated)

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.
June 30, 2021

Study Completion (Anticipated)

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.
September 30, 2021

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 29, 2019

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.
October 3, 2019

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 7, 2019

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 27, 2020

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, 2020

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, 2020

More Information

Terms related to this study

Keywords

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.
  • IR001094
  • 2019-142 (Other Identifier: 2nd Affiliated Hospital, School of Medicine, Zhejiang University)

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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