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

Sponsor
Vold Vision P.L.L.C (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04619654
Collaborator
Alcon Research (Industry)
25
Enrollment
1
Location
1
Arm
16.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective single arm open label descriptive case seriesProspective single arm open label descriptive case series
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cataract Surgery with concurrent MIGS

Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold
Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent

Outcome Measures

Primary Outcome Measures

  1. Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [3 months]

Secondary Outcome Measures

  1. Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR [3 months]

  2. Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR [3 months]

  3. Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [3 months]

  4. Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR [3 months]

  5. Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR [3 months]

  6. Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR [3 months]

  7. Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR [3 months]

  8. Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR [3 months]

  9. Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR [3 months]

  10. Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR [3 months]

  11. Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR [3 months]

  12. Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar [3 months]

  13. Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar [3 months]

Other Outcome Measures

  1. Mean Postoperative Refractive Spherical Equivalent [3 months]

  2. Absolute Prediction Error [3 months]

    Difference from postoperative refraction from preoperative biometry

  3. Quality of Vision Questionnaire (QoV) [3 months]

    Grading of dysphotopsia

  4. Spectacle-Dependence questionnaire [3 months]

    Gauging spectacle independence postoperatively

  5. Mean preoperative IOP versus postoperative IOP [3 months]

  6. Glaucoma Mean preoperative medications versus postoperative medications [3 months]

  7. 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 [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  1. Shaffer grade of greater than III in all quadrants

  2. Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively

  3. Able and willing to comply with follow up visits

  4. 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

  1. 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.

  2. 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.

  3. Pregnant or breastfeeding women

  4. Prior refractive surgery e.g. LASIK, RK, PRK, etc.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vold Vision P.L.L.C. Fayetteville Arkansas United States 72764

Sponsors and Collaborators

  • Vold Vision P.L.L.C
  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vold Vision P.L.L.C
ClinicalTrials.gov Identifier:
NCT04619654
Other Study ID Numbers:
  • PanOptix Trifocal 001, Rev A
First Posted:
Nov 6, 2020
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Vold Vision P.L.L.C
PanOptix
Trifocal IOL
Glaucoma
MIGS
Additional relevant MeSH terms:
Glaucoma
Cataract
Glaucoma, Open-Angle

Study Results

No Results Posted as of May 17, 2022