Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery

Recruiting

• Conditions: Cataract

• Registration Number: NCT06555289
• Lead Sponsor: Juliette Eye Institute Research Center

Brief Summary

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-15
• Study Start: 2024-10-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
• Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
• Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix spherical IOL.
• Patients who have regular corneal astigmatism and are candidates for PanOptix toric IOL T3
• Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.

Exclusion Criteria

• Any ocular comorbidity that might hamper postoperative visual acuity:

  • Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
  • Moderate or severe dry eyes that can't be relieved after treatment.
  • History of or current anterior and posterior inflammation of any etiology.
  • Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
  • Glaucoma of any kind.
  • Pregnancy or lactation.

• Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).

• Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)

• Apple Kappa/chord mu ≥ 0.6.

• Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)

• Any patient requiring a limbal relaxing incision.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binocular corrected distance visual acuity (logMAR)	3 months postoperative

Secondary Outcome Measures

Name	Time	Method
Binocular distance corrected visual acuity at intermediate (logMAR)	3 months postoperative
Binocular unccorrected visual acuity at distance (logMAR)	3 months postoperative
Binocular distance corrected visual acuity at near (logMAR)	3 months postoperative
Binocular unccorrected visual acuity at intermediate (logMAR)	3 months postoperative
Binocular unccorrected visual acuity at near (logMAR)	3 months postoperative

Trial Locations

Locations (1)

Juliette Eye Institute Research Center; 🇺🇸 Albuquerque, New Mexico, United States