Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma

November 6, 2022 updated by: Vold Vision P.L.L.C

Visual Acuity, Refractive Predictability, and Patient Reported Quality of Vision in Subjects Implanted With a Trifocal IOL With Stable Mild Open-Angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery

This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.

Study Overview

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects 45 years of age or older
  2. A visually significant cataract
  3. Diagnosis of mild OAG

    • Vertical C/D ratio of less than or equal to 0.8
    • 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 of less than or equal to mmHg on 1-3 medications
    • If treatment naïve (before glaucoma treatment) IOP between 21 and 35 mmHg
  4. 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
  5. Shaffer grade of greater than III in all quadrants
  6. Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
  7. Able and willing to comply with follow up visits
  8. Understands and signs the informed consent

Exclusion Criteria:

  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

    • 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
  6. 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.
  7. 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.
  8. Pregnant or breastfeeding women
  9. Prior refractive surgery e.g. LASIK, RK, PRK, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cataract Surgery with concurrent MIGS
Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time Frame: 3 months
3 months
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time Frame: 3 months
3 months
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time Frame: 3 months
3 months
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Postoperative Refractive Spherical Equivalent
Time Frame: 3 months
3 months
Absolute Prediction Error
Time Frame: 3 months
Difference from postoperative refraction from preoperative biometry
3 months
Quality of Vision Questionnaire (QoV)
Time Frame: 3 months
Grading of dysphotopsia
3 months
Spectacle-Dependence questionnaire
Time Frame: 3 months
Gauging spectacle independence postoperatively
3 months
Mean preoperative IOP versus postoperative IOP
Time Frame: 3 months
3 months
Glaucoma Mean preoperative medications versus postoperative medications
Time Frame: 3 months
3 months
Percentage of patients with an IOP of less than or equal to18 mmHg and less than or equal to15 mm Hg on no glaucoma medications postoperatively
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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 Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (ACTUAL)

November 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PanOptix Trifocal 001, Rev A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan to publish results in open access peer reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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