Clinical trial NCT06555289: Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery
Official title: Visual and Refractive Outcomes of the Clareon PanOptix IOL in Patients With Prior Myopic Refractive Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Lead sponsor: Juliette Eye Institute Research Center
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be those with age-related cataracts and prior myopic refractive surgery.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Binocular corrected distance visual acuity (logMAR)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Binocular distance corrected visual acuity at intermediate (logMAR)
timeFrame: 3 months postoperative
measure: Binocular distance corrected visual acuity at near (logMAR)
timeFrame: 3 months postoperative
measure: Binocular unccorrected visual acuity at distance (logMAR)
timeFrame: 3 months postoperative
measure: Binocular unccorrected visual acuity at intermediate (logMAR)
timeFrame: 3 months postoperative
measure: Binocular unccorrected visual acuity at near (logMAR)
timeFrame: 3 months postoperative
Other outcomes:
measure: Visual Disturbance Questionnaire
timeFrame: 3 months postoperative
measure: Satisfaction Questionnaire
timeFrame: 3 months postoperative
Locations:
city: Albuquerque
country: United States
facility: Juliette Eye Institute Research Center
state: New Mexico
Study officials:
affiliation: Juliette Eye Institute Research Center
name: Robert Melendez, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: