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Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation

Primary Purpose

Aphakia, Cataract

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doubled sutured SFIOL
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with phacodonesis, lens subluxation, insufficient capsular or zonular support, or surgical aphakia without adequate ciliary sulcus who are listed for scleral fixation intraocular lens implantation.

Exclusion Criteria:

  • Patients with previous corneal transplantation surgery or undergoing concomitant corneal transplantation at the time of scleral fixation intraocular lens implantation.
  • Patients undergoing concomitant vitreoretinal surgery at the time of intraocular lens implantation.
  • Monocular patients, or patients whose fellow eye had vision of equal or less than 20/200.
  • Patients who could not comprehend the risks and benefits of the surgery and/or the research study, including mentally incapacitated persons.
  • Patients with pre-existing macular pathologies including macular oedema, haemorrhage, degeneration or scar.
  • Patients with pre-existing iris abnormalities including aniridia, corectopia, extensive anterior synechiae formation resulting in inability to measure the IOL tilting postoperatively.
  • Patients with significantly reduced corneal endothelial cell density (of < 1000 cells/mm2) preoperatively which may necessitate a corneal transplantation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    The intervention arm will undergo the modified sutured SFIOL technique with double Prolene sutures instead of a single Prolene suture

    Outcomes

    Primary Outcome Measures

    Proportion of eyes with intraoperative, early (within 1 week) and late (at 12 months) postoperative complications following this modified technique of intraocular lens fixation.
    Complication Rate

    Secondary Outcome Measures

    Unaided and corrected visual acuities
    Visual acuities
    Intraocular lens tilting
    Anterior segment optical coherence tomography
    endothelial cell status
    specular microscopy

    Full Information

    First Posted
    August 14, 2020
    Last Updated
    August 14, 2020
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04516889
    Brief Title
    Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
    Official Title
    Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cataract is the leading cause of blindness globally and cataract surgery with the implantation of intraocular lens (IOL) is the most commonly performed operation worldwide. After removal of the cataract, an IOL is usually implanted within the capsular bag. However, endocapsular implantation of IOL is not always feasible due to inadequate zonular or capsular support, intraoperative posterior capsule rupture, or in primary intracapsular cataract extraction. Predisposing factors including prior ocular trauma, intravitreal injection or intraocular surgery, co-existing ocular comorbidities like chronic uveitis, pseudoexfoliation syndrome, may increase the risk of failure of in-the-bag implantation. In such situation, the surgeons may consider implanting the IOL in the anterior chamber, ciliary sulcus, or using fixation techniques. In Asian eyes, the anterior chambers are often shallow and placement in anterior chamber may accelerate corneal endothelial cell loss leading to corneal decompensation, or worsen pre-existing glaucoma. Placement in the ciliary sulcus depends on the amount and integrity of the capsular remnant, and inadequate support may result in dislocation of the IOL. In recent years, newer forms of scleral fixation of IOL using glue or glue-less approach, although these procedure appeared to be simpler, the long-term stability of these IOL have not been evaluated against conventional approach with suture fixation. The main limitations of suture fixation technique are related to the sutures either intraoperatively (e.g. entanglement, failure to rotate and bury the suture knot) or postoperatively (breakage, dissolution of suture with time), and the learning curve required for surgeons in training. Our study aims to study the efficacy and safety of a modified technique of scleral fixation of an intraocular lens in the posterior chamber.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphakia, Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention arm will undergo the modified sutured SFIOL technique with double Prolene sutures instead of a single Prolene suture
    Intervention Type
    Procedure
    Intervention Name(s)
    Doubled sutured SFIOL
    Intervention Description
    Recruited subjects would undergo implantation of SFIOL with the modified technique under either local or general anesthesia. The surgeon would mark the sclerotomies as per routine sutured SFIOL at 2mm behind the nasal and temporal limbus, followed by passage of 2 pairs of prolene sutures. The intraocular lens with islets would be implanted into the posterior chamber and sutured to the sclera as per single suture SFIOL.
    Primary Outcome Measure Information:
    Title
    Proportion of eyes with intraoperative, early (within 1 week) and late (at 12 months) postoperative complications following this modified technique of intraocular lens fixation.
    Description
    Complication Rate
    Time Frame
    up to 12 months
    Secondary Outcome Measure Information:
    Title
    Unaided and corrected visual acuities
    Description
    Visual acuities
    Time Frame
    up to 12 months
    Title
    Intraocular lens tilting
    Description
    Anterior segment optical coherence tomography
    Time Frame
    up to 12 months
    Title
    endothelial cell status
    Description
    specular microscopy
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients with phacodonesis, lens subluxation, insufficient capsular or zonular support, or surgical aphakia without adequate ciliary sulcus who are listed for scleral fixation intraocular lens implantation. Exclusion Criteria: Patients with previous corneal transplantation surgery or undergoing concomitant corneal transplantation at the time of scleral fixation intraocular lens implantation. Patients undergoing concomitant vitreoretinal surgery at the time of intraocular lens implantation. Monocular patients, or patients whose fellow eye had vision of equal or less than 20/200. Patients who could not comprehend the risks and benefits of the surgery and/or the research study, including mentally incapacitated persons. Patients with pre-existing macular pathologies including macular oedema, haemorrhage, degeneration or scar. Patients with pre-existing iris abnormalities including aniridia, corectopia, extensive anterior synechiae formation resulting in inability to measure the IOL tilting postoperatively. Patients with significantly reduced corneal endothelial cell density (of < 1000 cells/mm2) preoperatively which may necessitate a corneal transplantation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ka Wai Kam
    Phone
    +852 3505 2879
    Email
    dr.kwa.kam@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jackey Tse
    Phone
    +852 3505 2879
    Email
    jackey@cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alvin L Young
    Organizational Affiliation
    Prince of Wales Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluating Safety and Efficacy of a Modified Technique of Scleral Fixation Intraocular Lens Implantation

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