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NCT03581864 Clinical Trial

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

Aniridia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03581864
Other study ID # 0002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date May 1, 2018

Study information
Verified date June 2018
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date May 1, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 25 Years to 79 Years
Eligibility Inclusion Criteria:

post-traumatic complete aniridia and aphakia

Exclusion Criteria:

active ocluar inflammation or infection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Poland General Department of Ophthalmology in Lublin Lublin

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best-corrected visual acuity The visual acuity measurement with ETDRS chart 10 to 120 months
Primary The slit lamp examination The anterior segment of the eye and eye fundus were examined. 10 to 120 months
Primary The intrraocular pressure measurement The procedure was performed with the Goldman applanation tonometer. 10 to 120 months
Primary The medical history Coexisting eye diseases and post-operative complications were noted. 10 to 120 months
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