Clincosm LogoSign in Get a demo

Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05716269
Collaborator
Tianjin Eye Hospital (Other)
44
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate visual outcomes and patient satisfactory after PanOptix implantation in hyperopic cataract patients

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with axial length ≤22.5mm will be recruited. The subjects will undergo bilateral uneventful phacoemulsification and implantation of PanOptix. Visual quality and patients satisfactory will be assessed three months after the surgery.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    44 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Visual Outcomes and Patient Satisfactory After PanOptix Implantation in Hyperopic Cataract Patients: a Prospective, Cohort Study
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Best corrected distance visual acuity of the operated eye [3 months postoperatively]

      Best corrected distance visual acuity (BCDVA) of the operated eye will be measured.

    Secondary Outcome Measures

    1. Uncorrected distance visual acuity (UCVA) [3 months postoperatively]

      Uncorrected distance visual acuity (UCVA) of the operated eye will be measured at 5m.

    2. Uncorrected intermediate visual acuity [3 months postoperatively]

      Uncorrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.

    3. Uncorrected near visual acuity [3 months postoperatively]

      Uncorrected near visual acuity of the operated eye will be measured at 40cm.

    4. Best corrected intermediate visual acuity [3 months postoperatively]

      Best corrected intermediate visual acuity of the operated eye will be measured at 60cm and 80cm respectively.

    5. Best corrected near visual acuity [3 months postoperatively]

      Best corrected near visual acuity of the operated eye will be measured at 40cm.

    6. Manifest refraction spherical equivalent [3 months postoperatively]

      Manifest refraction spherical equivalent of the operated eye will be measured

    7. Visual disturbance, spectacle independence and patient satisfaction [3 months postoperatively]

      A questionnaire including visual disturbance, spectacle independence and patient satisfaction will be distributed to subjects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age-related cataract patients

    • Eye axis length ≤22.5mm and refraction ≥ +0.5D

    • Predicted postoperative corneal astigmatism ≤0.75D

    • mesopic pupil size between 3.0mm to 5.5 mm

    • Preoperative angle kappa ≤ 0.5 mm

    • Preoperative corneal spherical aberration <0.5μm, high order aberration <0.5μm

    Exclusion Criteria:

    • In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)

    • Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)

    • History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis

    • Patients with history of ocular trauma or prior ocular surgery including refractive procedures

    • Preoperative visual acuity of worse than 0.2 logMAR in any eye.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Third Hospital
    • Tianjin Eye Hospital

    Investigators

    • Principal Investigator: Hong Qi, MD, PhD, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Qi, Professor, Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05716269
    Other Study ID Numbers:
    • 2022756
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract
    Hyperopia

    Study Results

    No Results Posted as of Feb 8, 2023