The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance

Cataract Surgery Clinical Trial

Official title:

The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146961
• Other study ID #: ALC51819219
• Status: Completed
• Start date: October 5, 2019
• Est. completion date: July 21, 2020

Study information

• Verified date: January 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.

Description:

This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 21, 2020
• Est. primary completion date: April 10, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.

• Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.

• Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.

Exclusion Criteria:

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.

• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)

• Patients with greater than grade 1 posterior capsule opacity.

• Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Device:
• Alcon PanOptix or PanOptix Toric IOL
Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.

Locations

Country	Name	City	State
United States	Quantum Vision Center	Edwardsville	Illinois
United States	Harvard Eye Associates	Laguna Hills	California
United States	Quentin Allen	Palm City	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction, measured as the percentage of patients reporting "top box" satisfaction	Primary objective: to determine the percentage of patients who report "top box" (5 out of 5) overall satisfaction on the questionnaire instrument. To determine the percentage of patients who report satisfaction ("satisfied" or "very satisfied" as 4 out of 5 on the attached questionnaire instrument.	6/1/20 - 7/1/20
Secondary	Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."	To report spectacle independence, measured as the percentage of patients who do not require glasses for each of the common activities queried like driving, reading, computer work, watching TV, and sports/hobbies. To determine the incidence of glare and halos described by the patient as "a fair amount" or worse (Question 20).	6/1/20 - 7/1/20