RECRUITING

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery

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Conditions

Cataract

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro 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.

Official Title

Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery

Quick Facts

Study Start:2024-10-23
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555289

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.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
  2. * Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
  3. * Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
  4. * Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
  5. * Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.
  1. * Any ocular comorbidity that might hamper postoperative visual acuity:
  2. * Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
  3. * Moderate or severe dry eyes that can't be relieved after treatment.
  4. * History of or current anterior and posterior inflammation of any etiology.
  5. * Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
  6. * Glaucoma of any kind.
  7. * Pregnancy or lactation.
  8. * Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
  9. * Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
  10. * Apple Kappa/chord mu ≥ 0.6.
  11. * Higher order corneal aberrations at pupil diameter of 4mm: \> 0.6 total RMS, \> 0.3 coma, \> 0.3 trefoil (to exclude irregular corneas)
  12. * Any patient requiring a limbal relaxing incision.

Contacts and Locations

Study Contact

Zoe Baker, OD
CONTACT
505-355-2020
dr.baker@julietteeye.com

Principal Investigator

Robert Melendez, MD, MBA
PRINCIPAL_INVESTIGATOR
Juliette Eye Institute Research Center

Study Locations (Sites)

Juliette Eye Institute Research Center
Albuquerque, New Mexico, 87113
United States

Collaborators and Investigators

Sponsor: Juliette Eye Institute Research Center

  • Robert Melendez, MD, MBA, PRINCIPAL_INVESTIGATOR, Juliette Eye Institute Research Center

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 Registration Dates

Study Start Date2024-10-23
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-10-23
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cataract