Clincosm LogoSign in Get a demo

Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture

Sponsor
Medical University of Lublin (Other)
Overall Status
Completed
CT.gov ID
NCT03581864
Collaborator
(none)
14
Enrollment
1
Location
147.9
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: To assess long-term outcomes of implantation of black diaphragmintraocular lens (BD IOL) in postraumatic aniridia and aphakia due to eye rupture.

METHODS: This is retrospective consecutive case series of 14 eyes with post-traumatic complete aniridia and aphakia treated withscleral fixation of BD IOL with. Measurements included ophthalmological comorbidities, best corrected visual acuity (BCVA), complications, and postoperative interventions. The average postoperative follow-up period was 36 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
    Actual Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    Dec 31, 2017
    Actual Study Completion Date :
    May 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Group of 14 patients with post-traumatic complete anirirdia

    14 eyes with post-traumatic complete aniridia and aphakia treated withscleral fixation of BD IOL with measurements included ophthalmological comorbidities, best corrected visual acuity (BCVA), complications, and postoperative interventions.

    Outcome Measures

    Primary Outcome Measures

    1. Best-corrected visual acuity [10 to 120 months]

      The visual acuity measurement with ETDRS chart

    2. The slit lamp examination [10 to 120 months]

      The anterior segment of the eye and eye fundus were examined.

    3. The intrraocular pressure measurement [10 to 120 months]

      The procedure was performed with the Goldman applanation tonometer.

    4. The medical history [10 to 120 months]

      Coexisting eye diseases and post-operative complications were noted.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    post-traumatic complete aniridia and aphakia

    Exclusion Criteria:

    active ocluar inflammation or infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Department of Ophthalmology in Lublin Lublin Poland 20-001

    Sponsors and Collaborators

    • Medical University of Lublin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dominika Nowakowska, PhD, Medical University of Lublin
    ClinicalTrials.gov Identifier:
    NCT03581864
    Other Study ID Numbers:
    • 0002
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Jul 10, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dominika Nowakowska, PhD, Medical University of Lublin
    aphakia
    black diaphragmintraocular lens
    eye rupture
    aniridia
    Additional relevant MeSH terms:
    Aphakia
    Aniridia
    Rupture

    Study Results

    No Results Posted as of Jul 10, 2018