Open Angle GlaucomaNCT04202510
IOP and Medication Reduction in MIGS Procedures
A study testing Glaucoma and Cataract Surgery in people with Open Angle Glaucoma and Primary Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma
- What is being tested?
- Glaucoma and Cataract Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 12 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult male or female aged 40 years or more. 2. Patients able and willing to provide informed consent. 3. Patients having Visually Significant Age Related Cataract with Mild to Moderate Open Angle Glaucoma (OAG) on topical anti-glaucoma medication with or without previous Selective Laser Trabeculoplasty (SLT) ), including:
- Primary open angle glaucoma (POAG).
- Pigmentary glaucoma.
- Pseudoexfoliative glaucoma. 4. Patients should be candidate for safe mediaction wash out in the opinion of the investigator.
- The diagnosis of glaucoma is confirmd by optic nerve examination and the characteristic visual field defects on automated perimetry according to the American Academy of Ophthalmology (AAO) Definition and Criteria.
- The severity of glaucoma is classified using the Hodapp Parrish Anderson Visual Field Criteria depending on the Mean Deviation (MD):
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- Mild: MD no worse than -6 dB.
- Moderate: MD worse than -6 but no worse than -12 dB.
- Severe: MD worse than -12 dB.
Who cannot join
- Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
- Any prior glaucoma, corneal or vitreoretinal surgery.
- Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
- Abnormal angle anatomy.
- Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
- Any systemic condition or medications affectiong IOP.
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- Corneal opacity, corneal dystrophy or central corneal thickness (CCT) less than 480 or more than 620 microns.
- Exclusion from medications wash out according to the opinion of the investigator Or if any of the following is observed at any time point of the study:
- Visual Field: Mean deviation worse than -12 dB.
- Intraocular pressure: a treated IOP of greater than 24 mmHg.
- Medications: using more than three medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pressure Reduction and Medication Use Following Different Minimally Invasive Glaucoma Surgery Procedures, Prospective Randomized Clinical Trial of Efficacy
The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma.
Read the detailed description
Study Design Prospective Randomized Clinical Trial (Parallel Group Study)
Patients who fit inclusion criteria will be randomly assigned to one of the 3 parallel groups (one of the study surgical interventions combined with phacoemulsification) in the following order:
- 1st Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- 2nd Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- Hydrus Microstent (Ivantis Inc, Irvine, CA). Blocked randomization will be used in 1:1:1 ratio to provide balanced study groups. Allocation will be performed using a random number table.
Preoperative Evaluation of : Visual acuity, Slit lamp examination, IOP, Gonioscopy, Fundus Examination, Central corneal thickness (CCT), Endothelial Cell Count (ECC), Visual field, Retinal Nerve Fiber layer (RNFL) thickness by Optical Coherence Tomography (OCT) and Number and type of preoperative antiglaucoma medications.
Patients will be followed postoperatively at Day 1, Week 1, Months 1, 3, 6 and 12.
Medication Washout will be done at baseline, Months 6 and 12 to evaluate non-medicated IOP.
The duration of washout will be:
4 Weeks for Prostaglandin Analogues (PGA) and Beta Blockers (BB). 2 Weeks for Carbonic Anhydrase Inhibitors (CAI) and Alpha Agonists (AA).
The IOP measurements in the wash out visits:
will be performed according to 2-operator method to provide masking as described in Ocular Hypertension Treatment Study (OHTS) and Glaucoma World Association Guidelines.
- Conditions
- Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma in Both Eyes
- Being tested
- Glaucoma and Cataract Surgery
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma and Cataract SurgeryProcedure or surgery
Patients requiring combined cataract and glaucoma surgery will be randomized to either iStent, iStent Inject or Hydrus (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
| Study group | Role | What they receive |
|---|---|---|
| iStent | Active comparator | iStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery Receives: Procedure: Glaucoma and Cataract Surgery |
| iStent Inject | Active comparator | iStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery Receives: Procedure: Glaucoma and Cataract Surgery |
| Hydrus | Active comparator | Hydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery Receives: Procedure: Glaucoma and Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)
Measured: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Secondary outcomes (3)
Visual Acuity
Change in visual acuity after eye surgery measured in minimal angle of resolution (logMAR).
Measured: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Central Corneal Thickness (CCT)
Change in CCT after eye surgery measured in microns using pachymeter.
Measured: 1 hour examination at Baseline, Months 3, 6 and 12
Endothelial Cell Count
Change in endothelial cell count after eye surgery measured in number of cells by millimeter square using specular microscopy.
Measured: 1 hour examination at Baseline, Months 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start6 Jan 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Why it stopped: Due to COVID-19 and the decrease in surgical cases, sufficient patients were not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Daniel Lee, MD, Wills Eye
- Investigators
- Daniel Lee, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202510
- Sponsor's protocol ID
- IRB #19-869
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Reduction and Medication Use Following Different Minimally Invasive Glaucoma Surgery Procedures, Prospective Randomized Clinical Trial of Efficacy
- ClinicalTrials.gov ID
- NCT04202510
- Acronym / sponsor ID
- IRB #19-869
- Conditions
- Open Angle Glaucoma, Primary Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma in Both Eyes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 and the decrease in surgical cases, sufficient patients were not available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this research is to compare the efficacy of trabecular minimally invasive glaucoma surgery (MIGS) devices (iStent vs iStent Inject vs Hydrus) for intra ocular pressure (IOP) and anti-glaucoma medication reduction in open angle glaucoma.
Detailed description
Study Design Prospective Randomized Clinical Trial (Parallel Group Study)
Patients who fit inclusion criteria will be randomly assigned to one of the 3 parallel groups (one of the study surgical interventions combined with phacoemulsification) in the following order:
- 1st Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- 2nd Generation iStent, Trabecular Micro-Bypass Device (Glaukos Inc, San Clemente, CA).
- Hydrus Microstent (Ivantis Inc, Irvine, CA). Blocked randomization will be used in 1:1:1 ratio to provide balanced study groups. Allocation will be performed using a random number table.
Preoperative Evaluation of : Visual acuity, Slit lamp examination, IOP, Gonioscopy, Fundus Examination, Central corneal thickness (CCT), Endothelial Cell Count (ECC), Visual field, Retinal Nerve Fiber layer (RNFL) thickness by Optical Coherence Tomography (OCT) and Number and type of preoperative antiglaucoma medications.
Patients will be followed postoperatively at Day 1, Week 1, Months 1, 3, 6 and 12.
Medication Washout will be done at baseline, Months 6 and 12 to evaluate non-medicated IOP.
The duration of washout will be:
4 Weeks for Prostaglandin Analogues (PGA) and Beta Blockers (BB). 2 Weeks for Carbonic Anhydrase Inhibitors (CAI) and Alpha Agonists (AA).
The IOP measurements in the wash out visits:
will be performed according to 2-operator method to provide masking as described in Ocular Hypertension Treatment Study (OHTS) and Glaucoma World Association Guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iStent | Active comparator | Procedure: Glaucoma and Cataract SurgeryiStent Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery |
| iStent Inject | Active comparator | Procedure: Glaucoma and Cataract SurgeryiStent Inject Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery |
| Hydrus | Active comparator | Procedure: Glaucoma and Cataract SurgeryHydrus Trabecular Bypass Device (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Adult male or female aged 40 years or more. 2. Patients able and willing to provide informed consent. 3. Patients having Visually Significant Age Related Cataract with Mild to Moderate Open Angle Glaucoma (OAG) on topical anti-glaucoma medication with or without previous Selective Laser Trabeculoplasty (SLT) ), including:
Key exclusion criteria (11 listed)
- Glaucoma types rather than open angle glaucoma types mentioned in the inclusion criteria (Primary, Pigmentary and Pseudoexfoliation Glaucomas).
- Any prior glaucoma, corneal or vitreoretinal surgery.
- Evidence of concomitant retinal, optic nerve, or neurological diseases affecting the visual field.
- Abnormal angle anatomy.
- Prior Argon Laser Trabeculoplasty (ALT), Laser Iridotomy or Iridoplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glaucoma and Cataract SurgeryPatients requiring combined cataract and glaucoma surgery will be randomized to either iStent, iStent Inject or Hydrus (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery | Procedure or surgery | Hydrus, iStent, iStent Inject |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Reduction of IOP after eye surgery measured in millimeters of mercury (mmHg)
3 secondary outcomes
Visual Acuity
Time frame: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12
Central Corneal Thickness (CCT)
Time frame: 1 hour examination at Baseline, Months 3, 6 and 12
Endothelial Cell Count
Time frame: 1 hour examination at Baseline, Months 3, 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lee, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma and Cataract Surgery in people with Open Angle Glaucoma and Primary Open Angle Glaucoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: 1 hour examination at Baseline, Day 1, Week 1, Months 1, 3, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.