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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Subjects implanted with the Vivity IOL undergoing concurrent implantation of the Hydrus Microstent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivity IOL | Device | Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR | Visual acuity measurement | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR |
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
Glaucoma must be judged as stable by investigator based on review of subject medical records
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision P.L.L.C. | Recruiting | Fayetteville | Arkansas | 72764 | United States |
The investigators do not plan to share IPD
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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Prospective, single-center, single-surgeon, single-arm, descriptive study
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Visual acuity measurement
| 3 months |
| Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Refractive Spherical Equivalent | Average refractive error or residual spectacle prescription remaining following procedure (diopters) | 3 months |
| Mean Absolute Prediction Error | Average prescription remaining compared to preoperative prediction (diopters) | 3 months |
| Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D | Examining the distribution or remaining astigmatism in subjects | 3 months |
Visual acuity measurement
| 3 months |
| Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR | Visual acuity measurement | 3 months |
| Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR | Visual acuity measurement using "faded" letters | 3 months |
| Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR | Visual acuity measurement using "faded" letters | 3 months |
| Quality of Vision Questionnaire (QoV) | The QoV is a validated questionnaire designed to determine what if any visual disturbances are present following surgery. It consists of a 30-item instrument with 10 possible symptoms rated in each of 3 scales (frequency, severity, and bothersome). Examples of common visual disturbances include glare and halo. This outcome measure can be graded on a linear scale with a higher score being a worse outcome (more visual disturbances). This questionnaire takes approximately 5 minutes to complete. | 3 months |
| IOL patient satisfaction (IOLSAT) questionnaire | The IOLSAT is a questionnaire inquiring about the need for eyeglasses, vision without eyeglasses, expectations for needed eyeglasses, and visual satisfaction. It consists of 23 questions, the first 21 based on a Likert scale. Questions 22 asks whether the patient would choose the same lens again and 23 if they would recommend the lens to their family and friends. | 3 months |
| Mean preoperative IOP versus postoperative IOP | Comparing intraocular pressure before versus after intervention | 3 months |
| Mean preoperative medications versus postoperative medications | Comparing the amount of preoperative glaucoma medications before versus after intervention | 3 months |