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Quality of Vision in Implantable Collamer Lens (ICL)

Sponsor
He Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04982107
Collaborator
(none)
70
Enrollment
1
Location
3
Actual Duration (Months)
23.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to observe the influence of pupil size upon visual outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to observe the influence of pupil size upon the quality of vision outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation. Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be evaluated in patient that had ICL surgery.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Pupil Influence on the Quality of Vision in Implantable Collamer Lens (ICL)
    Actual Study Start Date :
    Jul 1, 2021
    Actual Primary Completion Date :
    Aug 30, 2021
    Actual Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Subjective Quality of vision [Baseline (before surgery) and 3 month after surgery]

      Change in QoV questionnaire score after ICL surgery at 3-month testing will be compare with baseline measurements

    2. Pupil diameter pre-operation and post-operation [Baseline (before surgery) and 3 month after surgery]

      Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

    3. Wave front aberrometry [baseline and 3 month after surgery]

      Change in Wave front aberrometry after ICL surgery at 3-month testing will be compare with baseline measurements

    4. Point Spread Function (PSF) [baseline and 3 month after surgery]

      Change in Point Spread Function (PSF) after ICL surgery at 3-month testing will be compare with baseline measurements

    5. Strehl ratio [Baseline and 3 month after surgery]

      Change in Pupil diameter after ICL surgery at 3-month testing will be compare with baseline measurements

    6. Modulation transfer function (MTF) [Baseline and 3 month after surgery]

      Change in Modulation transfer function after ICL surgery at 3-month testing will be compare with baseline measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Myopic eyes

    • Preoperative corneal endothelial cell count ≥2200/mm2

    • Preoperative central anterior chamber depth> 2.80mm

    • Intraocular pressure within the normal range (10-21mmHg)

    Exclusion Criteria:

    • Severe dry eye

    • Cataract and glaucoma

    • Patients with uveitis

    • Retinal detachment

    • Patients with autoimmune diseases

    • Patients with systemic diseases such as diabetes and hypertension

    • Patients with mental or cognitive abnormalities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 He Eye Specialist Hospital, Shenyang. Shenyang Liaoning China 110141

    Sponsors and Collaborators

    • He Eye Hospital

    Investigators

    • Study Chair: Wei He, He Eye Specialist Hospital, Shenyang.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    He Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT04982107
    Other Study ID Numbers:
    • ICL2020
    First Posted:
    Jul 29, 2021
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by He Eye Hospital
    ICL
    QoV
    Visual acuity

    Study Results

    No Results Posted as of Feb 1, 2022