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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract Surgery with concurrent MIGS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Postoperative Refractive Spherical Equivalent | 3 months | |
| Absolute Prediction Error | Difference from postoperative refraction from preoperative biometry | 3 months |
Inclusion Criteria:
Male or female subjects 45 years of age or older
A visually significant cataract
Diagnosis of mild OAG
Glaucoma must be judged as stable by investigator based on review of subject medical records
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
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision P.L.L.C. | Fayetteville | Arkansas | 72764 | United States |
Plan to publish results in open access peer reviewed journal
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective single arm open label descriptive case series
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| 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 |
| Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR | 3 months |
| Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR | 3 months |
| Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR | 3 months |
| Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR | 3 months |
| Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR | 3 months |
| Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR | 3 months |
| Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar | 3 months |
| Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar | 3 months |
| Quality of Vision Questionnaire (QoV) | Grading of dysphotopsia | 3 months |
| Spectacle-Dependence questionnaire | Gauging spectacle independence postoperatively | 3 months |
| Mean preoperative IOP versus postoperative IOP | 3 months |
| Glaucoma Mean preoperative medications versus postoperative medications | 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 | 3 months |