RECRUITING

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

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Conditions

Glaucoma, Open-AngleCataractGlaucomaMicrostentPremium IOL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-12-07
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05624398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects 45 years of age or older
  2. * A visually significant age-related cataract in both eyes
  3. * Diagnosis of mild OAG
  4. * 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)
  5. * Medicated IOP ≤25 mmHg on 1-3 hypotensive medications
  6. * Glaucoma must be judged as stable by investigator based on review of subject medical records
  7. * Stable VF at least 1 year prior to surgery
  8. * Stable nerve fiber layer at least 1 year prior to surgery
  9. * IOP stable on current medication regimen at least 3 months prior to surgery
  10. * Shaffer grade of ≥ III in all angle quadrants
  11. * Potential of best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
  12. * Able and willing to comply with follow up visits
  13. * Understands and signs the informed consent
  14. * 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
  1. * Previous incisional glaucoma surgery or cilio-ablative surgery
  2. * Prior laser trabeculoplasty within 90 days of surgery
  3. * Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
  4. * Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
  5. * Severe and/or progressive glaucoma defined as
  6. * VF mean deviation worse than -12.00 dB
  7. * Consistent worsening of visual field on review of subject medical records
  8. * Consistent and progressive thinning of nerve fiber layer on review of subject medical records
  9. * Uncontrolled IOP on maximum glaucoma medications
  10. * Historically poor IOP control with medical therapy
  11. * Severe focal notching of the optic nerve rim
  12. * Expectation for future need of incisional glaucoma surgery
  13. * 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
  14. * 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.
  15. * Pregnant or breastfeeding women
  16. * Prior refractive surgery e.g., LASIK, RK, PRK, etc.
  17. * Subjects with significant complications during surgical procedure e.g., broken capsule, Hydrus Microstent complication, will be exited from the trial
  18. * Subjects who experience visually significant complications related to the Hydrus Microstent during the study period will be exited from the trial

Contacts and Locations

Study Locations (Sites)

Vold Vision P.L.L.C.
Fayetteville, Arkansas, 72764
United States

Collaborators and Investigators

Sponsor: Vold Vision P.L.L.C

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-07
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2022-12-07
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • Glaucoma
  • Cataract
  • Microstent
  • Premium IOL

Additional Relevant MeSH Terms

  • Glaucoma, Open-Angle
  • Cataract