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The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04447157
Collaborator
(none)
9
Enrollment
47.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
    Actual Study Start Date :
    Jul 1, 2016
    Actual Primary Completion Date :
    Jun 10, 2020
    Actual Study Completion Date :
    Jun 20, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Microspherophakia

    This is a non-interventional study(NIS). All the patients diagnosed as microspherophakia are included in the study and recieved intraocular lens implantation

    Outcome Measures

    Primary Outcome Measures

    1. Visual function [6 month postoperation]

      Best corrected visual acuity (BCVA) measured using a decimal chart

    2. Visual function [6 month postoperation]

      uncorrected distance visual acuity (UDVA) measured using a decimal chart

    3. Intraocular pressure [6 month postoperation]

      intraocular pressure measured using non-contact tonometer

    4. PCIOL tilt degree [6 month postoperation]

      PCIOL tilt degree measured using Ultrasound biomicroscope

    5. PCIOL decentration distance [6 month postoperation]

      PCIOL decentration distance measured using Ultrasound biomicroscope

    6. Endothelial cell density [6 month postoperation]

      Endothelial cell density was measured by specular microscopy

    7. Anterior chamber depth [6 month postoperation]

      Anterior chamber depth measured using Ultrasound biomicroscope

    Eligibility Criteria

    Criteria

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

    • Microspherophakia was diagnosed and lens diameter<9mm;

    • The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;

    • Lens dislocated into the anterior chamber;

    • Lens dislocation caused elevated intraocular pressure (IOP);

    • The lens contacted the corneal endothelium;

    • Cataract;

    • Corneal endothelial cell density>1000/mm2;

    • The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；

    • There was possible improvement in postoperative visual acuity measured by retinometer.

    Exclusion Criteria:

    • The lens is centered and the position of the lens is stable;

    • Glasses can correct the vision obviously;

    • The reason for the elevated IOP was independent with the lens;

    • A high possibility of corneal decompensation after surgery;

    • Fundus function was poor and it is not expected to improve the vision after surgery;

    • Combined with other ocular diseases which were not suitable for IOL implantation;

    • Combined with a systemic disease that the patient cannot tolerate the surgery.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04447157
    Other Study ID Numbers:
    • xuwen2020-465
    First Posted:
    Jun 25, 2020
    Last Update Posted:
    Jun 30, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Corneal Diseases
    Ectopia Lentis
    Glaucoma

    Study Results

    No Results Posted as of Jun 30, 2020