Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification

June 7, 2023 updated by: Mohammadali Javadi, MD, Shahid Beheshti University of Medical Sciences

Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial

In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups ["NPDS and PE and autotransplantation of human anterior lens capsule (ALC)" and "NPDS and PE" alone]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 (Actual)

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.
66

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 Locations

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

  • Patients with concomitant uncontrolled glaucoma and significant cataract
  • Progression in glaucoma despite medical treatment
  • Age more than 18 years old

Exclusion criteria

  • Prior ocular surgery
  • Neovascular glaucoma or uveitic glaucoma
  • Compromised ocular surface or insufficient conjunctiva

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: 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.
Experimental: Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule
The intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake.
Procedure: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification with autotransplantation of anterior lens capsule.
Active Comparator: Non-penetrating deep sclerectomy and phacoemulsification
The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.
Procedure: Non-penetrating deep sclerectomy and phacoemulsification
This group will be undergoing nonpenetrating deep sclerectomy and phacoemulsification alone.

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
Change from baseline intraocular pressure at month 1 follow up
Time Frame: Baselines and month 1 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Baselines and month 1 follow up
Change from baseline intraocular pressure at month 3 follow up
Time Frame: Baselines and month 3 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Baselines and month 3 follow up
Change from baseline intraocular pressure at month 6 follow up
Time Frame: Baselines and month 6 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
Baselines and month 6 follow up
Change from baseline intraocular pressure at month 12 follow up
Time Frame: Baselines and month 12 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up
Baselines and month 12 follow up

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
The complete success rate at month 3 follow up
Time Frame: Month 3 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 3 follow up.
Month 3 follow up
The complete success rate at month 1 follow up
Time Frame: Month 1 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 1 follow up.
Month 1 follow up
The complete success rate at month 6 follow up
Time Frame: Month 6 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 6 follow up.
Month 6 follow up
The complete success rate at month 12 follow up
Time Frame: Month 12 follow up
The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication at month 12 follow up.
Month 12 follow up
The qualified success rate at month 3 follow up
Time Frame: Month 3 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 3 followup.
Month 3 follow up
The qualified success rate at month 6 follow up
Time Frame: Month 6 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 6 followup.
Month 6 follow up
The qualified success rate at the month 12 follow up
Time Frame: Month 12 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 12 followup.
Month 12 follow up
The qualified success rate at the month 1 follow up
Time Frame: Month 1 follow up
The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication at month 1 followup.
Month 1 follow up
Change from baseline the number of glaucoma medications at month 1 follow up
Time Frame: Baseline and month 1 follow up
The number of glaucoma medications will be assessed at baseline and month 1 follow up.
Baseline and month 1 follow up
Change from baseline the number of glaucoma medications at month 3 follow up
Time Frame: Baseline and month 3 follow up
The number of glaucoma medications will be assessed at baseline and month 3 follow up.
Baseline and month 3 follow up
Change from baseline the number of glaucoma medications at month 6 follow up
Time Frame: Baseline and month 6 follow up
The number of glaucoma medications will be assessed at baseline and month 6 follow up.
Baseline and month 6 follow up
Change from baseline the number of glaucoma medications at month 12 follow up
Time Frame: Baseline and month 12 follow up
The number of glaucoma medications will be assessed at baseline and month 12 follow up.
Baseline and month 12 follow up
Change from baseline the best-corrected visual acuity at month 6 follow up
Time Frame: Baseline and month 6 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 6 follow up.
Baseline and month 6 follow up
Change from baseline the best-corrected visual acuity at month 12 follow up
Time Frame: Baseline and month 12 follow up
The best-corrected visual acuity will be assessed using the Snellen chart at baseline and month 12 follow up.
Baseline and month 12 follow up
Complications at month 1 follow up
Time Frame: Month 1 follow up
The complications of surgery will be assessed at month 1 follow up.
Month 1 follow up
Complications at month 3 follow up
Time Frame: Month 3 follow up
The complications of surgery will be assessed at month 3 follow up.
Month 3 follow up
Complications at month 6 follow up
Time Frame: Month 6 follow up
The complications of surgery will be assessed at month 6 follow up.
Month 6 follow up
Complications at month 12 follow up
Time Frame: Month 12 follow up
The complications of surgery will be assessed at month 12 follow up.
Month 12 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Time Frame: Month 1 follow up
Need to postoperative needling and laser goniopuncture at month 1 follow up
Month 1 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Time Frame: Month 3 follow up
Need to postoperative needling and laser goniopuncture at month 3 follow up
Month 3 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Time Frame: Month 6 follow up
Need to postoperative needling and laser goniopuncture at month 6 follow up
Month 6 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Time Frame: Month 12 follow up
Need to postoperative needling and laser goniopuncture at month 12 follow up
Month 12 follow up

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.
Shahid Beheshti University of Medical Sciences

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 16, 2023

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 16, 2024

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 16, 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).
May 16, 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.
June 7, 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.
June 15, 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.
June 15, 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.
June 7, 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.
June 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.
  • 14021

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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