Clinical trial NCT05624398: Results of Patients With Glaucoma Undergoing Minimally Invasive Glaucoma Surgery in Conjunction With Cataract Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Cataract
Keywords: Glaucoma
Cataract
Microstent
Premium IOL
Lead sponsor: Vold Vision P.L.L.C
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-11-22
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-center, single-surgeon, single-arm, descriptive study
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
timeFrame: 3 months
Secondary outcomes:
measure: Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (66 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (66 cm) logMAR
timeFrame: 3 months
measure: Mean Refractive Spherical Equivalent
timeFrame: 3 months
measure: Mean Absolute Prediction Error
timeFrame: 3 months
measure: Mean post-op refractive astigmatism and the distribution of post-op refractive astigmatism at ≤0.25D, ≤0.50D, ≤0.75D, and ≤1.00D
timeFrame: 3 months
Other outcomes:
measure: Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMAR
timeFrame: 3 months
measure: Quality of Vision Questionnaire (QoV)
timeFrame: 3 months
measure: IOL patient satisfaction (IOLSAT) questionnaire
timeFrame: 3 months
measure: Mean preoperative IOP versus postoperative IOP
timeFrame: 3 months
measure: Mean preoperative medications versus postoperative medications
timeFrame: 3 months
Locations:
city: Fayetteville
country: United States
facility: Vold Vision P.L.L.C.
state: Arkansas
Study officials:
References: