NCT03581864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

12 years

First QC Date

May 30, 2018

Last Update Submit

June 26, 2018

Conditions

Aphakia Due to TraumaEye; Rupture, Traumatic, With Loss of Intraocular TissueAniridia

Keywords

aphakiablack diaphragmintraocular lenseye ruptureaniridia

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age25 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients

You may qualify if:

  • post-traumatic complete aniridia and aphakia

You may not qualify if:

  • active ocluar inflammation or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Department of Ophthalmology in Lublin

Lublin, 20-001, Poland

Location

MeSH Terms

Conditions

RuptureAniridiaAphakia

Condition Hierarchy (Ancestors)

Wounds and InjuriesEye AbnormalitiesEye DiseasesEye Diseases, HereditaryIris DiseasesUveal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornLens Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 30, 2018

First Posted

July 10, 2018

Study Start

January 1, 2006

Primary Completion

December 31, 2017

Study Completion

May 1, 2018

Last Updated

July 10, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)