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CompletedNCT03581864Updated Jul 10, 2018

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

An observational study in Aphakia Due to Trauma, Eye; Rupture, Traumatic, With Loss of Intraocular Tissue and Aniridia, sponsored by Medical University of Lublin. Completed at 1 site in Poland. Open to participants aged 25 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by Medical University of Lublin · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
14
Ages
25 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • aphakia
  • black diaphragmintraocular lens
  • eye rupture
  • aniridia
03

In context

Aphakia

70 studies on the registry are indexed under Aphakia; 7 are open to participants now.

This study's enrollment of 14 is below the median of 95 across 13 observational studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Medical University of Lublin is the lead sponsor of 60 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

consecutive patients

Inclusion criteria

post-traumatic complete aniridia and aphakia

Exclusion criteria

Exclusion Criteria:

active ocluar inflammation or infection

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and 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.

06

What researchers measure

Primary outcomes

  1. Best-corrected visual acuity

    The visual acuity measurement with ETDRS chart

    Time frame: 10 to 120 months

  2. The slit lamp examination

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

    Time frame: 10 to 120 months

  3. The intrraocular pressure measurement

    The procedure was performed with the Goldman applanation tonometer.

    Time frame: 10 to 120 months

  4. The medical history

    Coexisting eye diseases and post-operative complications were noted.

    Time frame: 10 to 120 months

07

Study locations

1 site
  • General Department of Ophthalmology in Lublin
    Lublin, 20-001, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03581864
Lead sponsor
Medical University of Lublin
Responsible party
Dominika Nowakowska (PhD, Medical University of Lublin) — Principal investigator
First posted
Jul 10, 2018
Start date
Jan 1, 2006
Primary completion
Dec 31, 2017
Completion
May 1, 2018
Last update
Jul 10, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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