- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619654
Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma
November 6, 2022 updated by: Vold Vision P.L.L.C
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72764
- Vold Vision P.L.L.C.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cataract Surgery with concurrent MIGS
|
Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
Time Frame: 3 months
|
3 months
|
Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time Frame: 3 months
|
3 months
|
Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Postoperative Refractive Spherical Equivalent
Time Frame: 3 months
|
3 months
|
|
Absolute Prediction Error
Time Frame: 3 months
|
Difference from postoperative refraction from preoperative biometry
|
3 months
|
Quality of Vision Questionnaire (QoV)
Time Frame: 3 months
|
Grading of dysphotopsia
|
3 months
|
Spectacle-Dependence questionnaire
Time Frame: 3 months
|
Gauging spectacle independence postoperatively
|
3 months
|
Mean preoperative IOP versus postoperative IOP
Time Frame: 3 months
|
3 months
|
|
Glaucoma Mean preoperative medications versus postoperative medications
Time Frame: 3 months
|
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
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2021
Primary Completion (ACTUAL)
June 1, 2022
Study Completion (ACTUAL)
June 1, 2022
Study Registration Dates
First Submitted
November 2, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (ACTUAL)
November 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 6, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PanOptix Trifocal 001, Rev A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Plan to publish results in open access peer reviewed journal
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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