NCT05624398 · Vold Vision P.L.L.C
Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
What this study is about
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.
View original scientific description
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. Patients will also undergo a minimally invasive type of glaucoma surgery using a special type of stent to reduce eye pressure, with the goal of better glaucoma control and the reduction in the need for medications to control eye pressure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female subjects 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 hemorrhage, nerve fiber layer loss)
- 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
Exclusion criteria
- 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 of significant ocular trauma with sequela, etc.
- Pregnant or breastfeeding women
- Prior refractive surgery e.g., LASIK, RK, PRK, etc.
- Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial
- Subjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial
Where
- Fayetteville, Arkansas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2024 · Source of record for eligibility and locations