Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy

February 28, 2023 updated by: Yuhong Chen, Eye & ENT Hospital of Fudan University

Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial

To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.

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.

Detailed Description

Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.

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.
316

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
      • Shanghai, China, 200031
        • Recruiting
        • Eye & ENT Hospital
        • 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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 40 years old to 80 years old
  2. more than 180-degree synechial closure of anterior chamber angle on gonioscopy
  3. IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
  4. mean deviation of visual field worse than -12dB on Humphrey 24-2
  5. phakic eyes

Exclusion Criteria:

  1. Snellen visual acuity worse than 0.02
  2. history of ocular trauma
  3. uveitis
  4. previous ocular surgeries
  5. significant conjunctival scar
  6. visible neovascular on iris or anterior chamber angle
  7. other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.

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: Triple

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: Lens extraction combined with goniosynechialysis group
One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent phacoemulsification combined with goniosynechialysis.
Procedure: Lens extraction combined with goniosynechialysis
The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
Active Comparator: Trabeculectomy Group
One hundred and fifty-eight patients with advanced angle-closure glaucoma underwent trabeculectomy.
Procedure: Trabeculectomy surgery
The patients enrolled underwent trabeculectomy surgery

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
Intraocular pressure (IOP) change at one month
Time Frame: one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
one month
IOP change at three months
Time Frame: three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
three months
IOP change at six months
Time Frame: six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
six months
IOP change at one year
Time Frame: one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
one year
IOP change at two years
Time Frame: two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
two years
IOP change at three years
Time Frame: three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
three years
Best corrected visual acuity at one month
Time Frame: one month
Best corrected visual acuity of participants after surgery at one month
one month
Best corrected visual acuity at three months
Time Frame: three months
Best corrected visual acuity of participants after surgery at three months
three months
Best corrected visual acuity at six months
Time Frame: six months
Best corrected visual acuity of participants after surgery at six months
six months
Best corrected visual acuity at one year
Time Frame: one year
Best corrected visual acuity of participants after surgery at one year
one year
Best corrected visual acuity at two years
Time Frame: two years
Best corrected visual acuity of participants after surgery at two years
two years
Best corrected visual acuity at three years
Time Frame: three years
Best corrected visual acuity of participants after surgery at three years
three years

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
Mean deviation
Time Frame: one month, three months, six months, one year, two years, three years
The mean deviation value of Humphery visual filed tests before and after surgery.
one month, three months, six months, one year, two years, three years
The thickness of retinal nerve fiber layer (RNFL)
Time Frame: one month, three months, six months, one year, two years, three years
The RNFL thickness measured by optical coherence topography (OCT)
one month, three months, six months, one year, two years, three years
The thickness of ganglion cell complex (GCC)
Time Frame: one month, three months, six months, one year, two years, three years
The GCC thickness measured by OCT
one month, three months, six months, one year, two years, three years
Number of eye drops
Time Frame: one month, three months, six months, one year, two years, three years
The number of eye drops after surgery.
one month, three months, six months, one year, two years, three years
Adverse event
Time Frame: one month, three months, six months, one year, two years, three years
Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage
one month, three months, six months, one year, two years, three years

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.
Eye & ENT Hospital of Fudan 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.
January 30, 2021

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.
December 1, 2024

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.
December 1, 2024

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).
January 3, 2021

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.
January 8, 2021

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.
January 11, 2021

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.
March 1, 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.
February 28, 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.
February 1, 2023

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.
  • AAC Glaucoma

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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