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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619654
• Other study ID #: PanOptix Trifocal 001, Rev A
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2022
• Source: Vold Vision P.L.L.C
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• IOL

Intervention

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

Locations

Country	Name	City	State
United States	Vold Vision P.L.L.C.	Fayetteville	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Vold Vision P.L.L.C	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Postoperative Refractive Spherical Equivalent		3 months
Other	Absolute Prediction Error	Difference from postoperative refraction from preoperative biometry	3 months
Other	Quality of Vision Questionnaire (QoV)	Grading of dysphotopsia	3 months
Other	Spectacle-Dependence questionnaire	Gauging spectacle independence postoperatively	3 months
Other	Mean preoperative IOP versus postoperative IOP		3 months
Other	Glaucoma Mean preoperative medications versus postoperative medications		3 months
Other	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
Primary	Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR		3 months
Secondary	Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR		3 months
Secondary	Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR		3 months
Secondary	Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR		3 months
Secondary	Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR		3 months
Secondary	Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR		3 months
Secondary	Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR		3 months
Secondary	Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR		3 months
Secondary	Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR		3 months
Secondary	Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR		3 months
Secondary	Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR		3 months
Secondary	Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR		3 months
Secondary	Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar		3 months
Secondary	Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar		3 months