Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery

Официальное название

Visual Outcomes and Patient Satisfaction in Subjects With Stable Open-angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery and IOL Implantation With an Extended-depth-of-focus IOL

Обзор

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.

Подробное описание

To evaluate the range of vision and patient reported outcomes in subjects implanted with Clareon Vivity IOL undergoing concurrent MIGS with the Hydrus Microstent

Вмешательства

• Устройство Vivity IOL
  Cataract surgery with implantation of the Vivity IOL along with concurrent implantation of the Hydrus Microstent

Первичные конечные точки

• Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [Срок оценки: 3 months]

Вторичные конечные точки (10)

• Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR [Срок оценки: 3 months]
• Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [Срок оценки: 3 months]
• Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR [Срок оценки: 3 months]
• Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [Срок оценки: 3 months]
• Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR [Срок оценки: 3 months]
• Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [Срок оценки: 3 months]
• Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR [Срок оценки: 3 months]
• Mean Refractive Spherical Equivalent [Срок оценки: 3 months]
• Mean Absolute Prediction Error [Срок оценки: 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 [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Vold Vision P.L.L.C. — Fayetteville

Идентификаторы

NCT: NCT05624398 · Vivity Protocol 001, Rev A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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