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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

Tracking Information
First Submitted Date May 30, 2018
First Posted Date July 10, 2018
Last Update Posted Date July 10, 2018
Actual Study Start Date January 1, 2006
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2018)
  • Best-corrected visual acuity [ Time Frame: 10 to 120 months ]
    The visual acuity measurement with ETDRS chart
  • The slit lamp examination [ Time Frame: 10 to 120 months ]
    The anterior segment of the eye and eye fundus were examined.
  • The intrraocular pressure measurement [ Time Frame: 10 to 120 months ]
    The procedure was performed with the Goldman applanation tonometer.
  • The medical history [ Time Frame: 10 to 120 months ]
    Coexisting eye diseases and post-operative complications were noted.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
Official Title Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population consecutive patients
Condition
  • Aphakia Due to Trauma
  • Eye; Rupture, Traumatic, With Loss of Intraocular Tissue
  • Aniridia
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2018)
14
Original Actual Enrollment Same as current
Actual Study Completion Date May 1, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

post-traumatic complete aniridia and aphakia

Exclusion Criteria:

active ocluar inflammation or infection

Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03581864
Other Study ID Numbers 0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dominika Nowakowska, Medical University of Lublin
Study Sponsor Medical University of Lublin
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University of Lublin
Verification Date June 2018