Clinical trial NCT04619654: Visual Outcomes With a Trifocal IOL in Subjects With Open-angle Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
IOL
Glaucoma, Open-Angle
Keywords: PanOptix
Trifocal IOL
Glaucoma
MIGS
Lead sponsor: Vold Vision P.L.L.C
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-11-06
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single arm open label descriptive case series
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
timeFrame: 3 months
Secondary outcomes:
measure: Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR
timeFrame: 3 months
measure: Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
timeFrame: 3 months
measure: Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar
timeFrame: 3 months
Other outcomes:
measure: Mean Postoperative Refractive Spherical Equivalent
timeFrame: 3 months
measure: Absolute Prediction Error
timeFrame: 3 months
measure: Quality of Vision Questionnaire (QoV)
timeFrame: 3 months
measure: Spectacle-Dependence questionnaire
timeFrame: 3 months
measure: Mean preoperative IOP versus postoperative IOP
timeFrame: 3 months
measure: Glaucoma Mean preoperative medications versus postoperative medications
timeFrame: 3 months
measure: 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
timeFrame: 3 months
Locations:
city: Fayetteville
country: United States
facility: Vold Vision P.L.L.C.
state: Arkansas
Study officials:
References: