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

NCT04619654 | Completed FDA Device

• 1 other identifier: PanOptix Trifocal 001, Rev A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; IOL; Glaucoma, Open-Angle

Keywords

PanOptix; Trifocal IOL; Glaucoma; MIGS

Outcome Measures

Primary Outcomes (1)

• Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR

  3 months

Secondary Outcomes (13)

• Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR

  3 months

• Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR

  3 months

• Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR

  3 months

Other Outcomes (7)

• Mean Postoperative Refractive Spherical Equivalent

  3 months

• Absolute Prediction Error

  3 months

• Quality of Vision Questionnaire (QoV)

  3 months

Study Arms (1)

Cataract Surgery with concurrent MIGS

EXPERIMENTAL

Procedure: Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold

Interventions

Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold PROCEDURE

Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent

Cataract Surgery with concurrent MIGS

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 45 years of age or older
• A visually significant cataract
• 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
• 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 greater than III in all quadrants
• Potential of good 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vold Vision P.L.L.C: lead
• Alcon Research: collaborator

Study Sites (1)

Vold Vision P.L.L.C.

Fayetteville, Arkansas, 72764, United States

Location

MeSH Terms

Conditions

Cataract; Glaucoma, Open-Angle; Glaucoma

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single arm open label descriptive case series

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: February 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)