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

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ClinicalTrials.gov Identifier: NCT03581864
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Dominika Nowakowska, Medical University of Lublin

Study Description
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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
Aphakia Due to Trauma Eye; Rupture, Traumatic, With Loss of Intraocular Tissue Aniridia

Study Design
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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 : January 1, 2006
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: 10 to 120 months ]
    The visual acuity measurement with ETDRS chart

  2. The slit lamp examination [ Time Frame: 10 to 120 months ]
    The anterior segment of the eye and eye fundus were examined.

  3. The intrraocular pressure measurement [ Time Frame: 10 to 120 months ]
    The procedure was performed with the Goldman applanation tonometer.

  4. The medical history [ Time Frame: 10 to 120 months ]
    Coexisting eye diseases and post-operative complications were noted.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients
Criteria

Inclusion Criteria:

post-traumatic complete aniridia and aphakia

Exclusion Criteria:

active ocluar inflammation or infection

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581864


Locations
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Poland
General Department of Ophthalmology in Lublin
Lublin, Poland, 20-001
Sponsors and Collaborators
Medical University of Lublin
More Information
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Responsible Party: Dominika Nowakowska, PhD, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03581864    
Other Study ID Numbers: 0002
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dominika Nowakowska, Medical University of Lublin:
aphakia
black diaphragmintraocular lens
eye rupture
aniridia
Additional relevant MeSH terms:
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Aphakia
Aniridia
Rupture
Wounds and Injuries
Lens Diseases
Eye Diseases
 Eye Abnormalities
Eye Diseases, Hereditary
Iris Diseases
Uveal Diseases
Congenital Abnormalities
Genetic Diseases, Inborn