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Outcome of Cataract Surgery With Uveitis

Primary Purpose

Cataract; Complicata

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cataract; Complicata focused on measuring uveitis

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month.

Exclusion Criteria:

  • Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment.
  • Patients with active uveitis (means inflammation inside the eye).
  • Patients less than 16 years old.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Uncorrected and best corrected visual acuity

    Arm Description

    Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery

    Outcomes

    Primary Outcome Measures

    final postoperative uncorrected visual acuity (UCVA)
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    final postoperative uncorrected visual acuity (UCVA)
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    final postoperative uncorrected visual acuity (UCVA)
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    final postoperative uncorrected visual acuity (UCVA)
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    Final post operative best corrected visual acuity (BCVA)
    Post operative visual acuity with spectacle correction
    Final post operative best corrected visual acuity (BCVA)
    Post operative visual acuity with spectacle correction
    Final post operative best corrected visual acuity (BCVA)
    Post operative visual acuity with spectacle correction
    Final post operative best corrected visual acuity (BCVA)
    Post operative visual acuity with spectacle correction

    Secondary Outcome Measures

    incidence of postoperative complications
    cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
    Reactivation of intraocular inflammation
    Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months

    Full Information

    First Posted
    March 28, 2020
    Last Updated
    April 1, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04333069
    Brief Title
    Outcome of Cataract Surgery With Uveitis
    Official Title
    Outcome of Cataract Surgery in Patient With Uveitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 10, 2020 (Anticipated)
    Primary Completion Date
    May 20, 2022 (Anticipated)
    Study Completion Date
    December 20, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Aim of the study is to evaluate outcome of cataract surgery in different types of uveitis as regarding best corrected visual acuity (BCVA) and rate of post operative complications.
    Detailed Description
    Cataract is the main cause of reversible blindness in patients with uveitis. Cataract occurs in up to 50% to 70% of patients with uveitis. Preoperative complications, including anterior synechiae, posterior synechiae, and pupillary membrane formation, may increase surgical challenges. In addition, recurrent inflammation increases the incidence of postoperative complications and often affects the visual prognosis. In recent years, phacoemulsification with intra ocular lens (IOL)implantation has become the main surgical method for treating uveitis (complicated cataract), and the visual prognosis of patients who undergo this procedure is usually favorable. Surgical treatment may be effective but is associated with higher rates of complication than in non uveitic eyes. Cystoid macular edema (CME) is the most common complication cataract surgery in the general population. Although, in most cases, the macular edema is self-limited, in rare cases it can lead to long-term visual deterioration that is difficult to treat. Another common complication after cataract surgery is posterior capsule opacification (PCO) , leading to symptoms of glare or blurred vision, reduced visual acuity, or impaired posterior segment exam. Factors that are critical in the development of PCO include surgical technique, type of implanted intra ocular lens (IOL) either foldable hydrophilic acrylic, hydrophobic acrylic or silicone and postoperative control of uveitis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract; Complicata
    Keywords
    uveitis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Uncorrected and best corrected visual acuity
    Arm Type
    Other
    Arm Description
    Measuring of uncorrected and best corrected visual acuity after phaco emulsification and irrigation aspiration cataract surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery
    Intervention Description
    cataract surgery in form of phaco emulsification or irrigation aspiration
    Primary Outcome Measure Information:
    Title
    final postoperative uncorrected visual acuity (UCVA)
    Description
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    Time Frame
    1 week post operative
    Title
    final postoperative uncorrected visual acuity (UCVA)
    Description
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    Time Frame
    1month post operative
    Title
    final postoperative uncorrected visual acuity (UCVA)
    Description
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    Time Frame
    3months post operative
    Title
    final postoperative uncorrected visual acuity (UCVA)
    Description
    post operative uncorrected visual acuity which mean visual acuity without spectacle correction
    Time Frame
    6months post operative
    Title
    Final post operative best corrected visual acuity (BCVA)
    Description
    Post operative visual acuity with spectacle correction
    Time Frame
    1 week post operative
    Title
    Final post operative best corrected visual acuity (BCVA)
    Description
    Post operative visual acuity with spectacle correction
    Time Frame
    1month post operative
    Title
    Final post operative best corrected visual acuity (BCVA)
    Description
    Post operative visual acuity with spectacle correction
    Time Frame
    3months post operative
    Title
    Final post operative best corrected visual acuity (BCVA)
    Description
    Post operative visual acuity with spectacle correction
    Time Frame
    6months post operative
    Secondary Outcome Measure Information:
    Title
    incidence of postoperative complications
    Description
    cystoid macular edema which mean inflammation, swelling and collection of fluid inside macula) .
    Time Frame
    6 months post operative
    Title
    Reactivation of intraocular inflammation
    Description
    Appearance of inflammatory activity inside the eye after period of quiescence of at least 6 months
    Time Frame
    6 months post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Visually significant cataract ( means opacification of the crystalline lens adequate to interfere with vision)in patients with uveitis controlled for at least 1month. Exclusion Criteria: Irreversible pathology affecting outcome e.g. macular scar ,optic atrophy, and retinal detachment. Patients with active uveitis (means inflammation inside the eye). Patients less than 16 years old.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Abdallah Abd AlRazik Ahmed, MD
    Phone
    01014398129
    Email
    monaabdallah51290@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed Gamal Saleh, lecturer
    Phone
    01004530716
    Email
    mgsaleh05@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashraf Khalaf Al Husseini, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Wael Mohammed Ahmed Soliman, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32157612
    Citation
    Carpentier SJ, Jung JL, Patnaik JL, Pecen PE, Palestine AG. A Cross-Sectional Online Survey Identifies Subspecialty Differences in the Management of Pediatric Cataracts Associated with Uveitis. Ophthalmol Ther. 2020 Jun;9(2):293-303. doi: 10.1007/s40123-020-00245-x. Epub 2020 Mar 10.
    Results Reference
    background
    PubMed Identifier
    31788579
    Citation
    Chen JL, Bhat P, Lobo-Chan AM. Perioperative Management of Uveitic Cataracts. Adv Ophthalmol Optom. 2019 Aug;4:325-339. doi: 10.1016/j.yaoo.2019.04.014. Epub 2019 May 18.
    Results Reference
    background
    PubMed Identifier
    30900580
    Citation
    Yangzes S, Seth NG, Singh R, Gupta PC, Jinagal J, Pandav SS, Gupta V, Gupta A, Ram J. Long-term outcomes of cataract surgery in children with uveitis. Indian J Ophthalmol. 2019 Apr;67(4):490-495. doi: 10.4103/ijo.IJO_846_18.
    Results Reference
    background
    PubMed Identifier
    30574896
    Citation
    Jinagal J, Gupta G, Agarwal A, Aggarwal K, Akella M, Gupta V, Suri D, Gupta A, Singh S, Ram J. Safety and efficacy of dexamethasone implant along with phacoemulsification and intraocular lens implantation in children with juvenile idiopathic arthritis associated uveitis. Indian J Ophthalmol. 2019 Jan;67(1):69-74. doi: 10.4103/ijo.IJO_713_18.
    Results Reference
    background
    PubMed Identifier
    30203671
    Citation
    El Gharbawy SA, Darwish EA, Abu Eleinen KG, Osman MH. Efficacy of addition of nepafenac 0.1% to steroid eye drops in prevention of post-phaco macular edema in high-risk eyes. Eur J Ophthalmol. 2019 Jul;29(4):453-457. doi: 10.1177/1120672118799626. Epub 2018 Sep 11.
    Results Reference
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    Outcome of Cataract Surgery With Uveitis

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