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

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    25
  • sponsor
    Vold Vision P.L.L.C
Updated on 15 April 2021

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.

Details
Condition Cataract, Pigmentary glaucoma, Cataracts, Open Angle Glaucoma, IOL
Treatment Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold
Clinical Study IdentifierNCT04619654
SponsorVold Vision P.L.L.C
Last Modified on15 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 nave (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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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