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

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.

Study Overview

• Status: Completed
• Conditions: Aniridia; Aphakia Due to Trauma; Eye; Rupture, Traumatic, With Loss of Intraocular Tissue

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-001
    • General Department of Ophthalmology in Lublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive patients

Description

Inclusion Criteria:

post-traumatic complete aniridia and aphakia

Exclusion Criteria:

active ocluar inflammation or infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Lublin

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2006
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (ACTUAL): July 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: aniridia; aphakia; black diaphragmintraocular lens; eye rupture
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Congenital Abnormalities; Eye Abnormalities; Genetic Diseases, Inborn; Uveal Diseases; Eye Diseases, Hereditary; Lens Diseases; Iris Diseases; Rupture; Aphakia; Aniridia
• Other Study ID Numbers: 0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No