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New treatment option for Glaucoma, Open-Angle
Official title Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
ClinicalTrials.gov ID: NCT05624398
What this study is testing
- What it's testing
- This study is designed to determine how well patients with glaucoma can see following cataract surgery with a special type of lens called an extended-depth-of-focus (EDOF) lens. This lens is intended to reduced the patients need for glasses following cataract surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Male or female people 45 years of age or older
- A visually significant age-related cataract in both eyes
- Diagnosis of mild OAG
- VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve...
- Medicated IOP ≤25 mmHg on 1-3 hypotensive medications
You likely can't join if
- Previous incisional glaucoma surgery or cilio-ablative surgery
- Prior laser trabeculoplasty within 90 days of surgery
- Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
- Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
- Severe and/or progressive glaucoma defined as
- VF mean deviation worse than -12.00 dB
See the full eligibility criteria
- Male or female people 45 years of age or older
- A visually significant age-related cataract in both eyes
- Diagnosis of mild OAG
- VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc...
- Medicated IOP ≤25 mmHg on 1-3 hypotensive medications
- Glaucoma must be judged as stable by investigator based on review of subject medical records
- Stable VF at least 1 year prior to surgery
- Stable nerve fiber layer at least 1 year prior to surgery
- IOP stable on current medication regimen at least 3 months prior to surgery
- Shaffer grade of ≥ III in all angle quadrants
- Potential of best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
- Able and willing to comply with follow up visits
- Understands and signs the informed consent
- Both eyes of the subject should undergo surgery within 21 days of each other to ensure adequate timing for final visit window of 90 days ± 21 days post operatively
- Previous incisional glaucoma surgery or cilio-ablative surgery
- Prior laser trabeculoplasty within 90 days of surgery
- Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
- Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
- Severe and/or progressive glaucoma defined as
- VF mean deviation worse than -12.00 dB
- Consistent worsening of visual field on review of subject medical records
- Consistent and progressive thinning of nerve fiber layer on review of subject medical records
- Uncontrolled IOP on maximum glaucoma medications
- Historically poor IOP control with medical therapy
- Severe focal notching of the optic nerve rim
- Expectation for future need of incisional glaucoma surgery
- Ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period
- Ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e., significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history...
- Pregnant or breastfeeding women
- Prior refractive surgery e.g., LASIK, RK, PRK, etc.
- people with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial
- people who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.