Aphakia Due to TraumaNCT03581864
Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
An observational study of Aphakia Due to Trauma and Eye; Rupture, Traumatic, With Loss of Intraocular Tissue, run by Medical University of Lublin at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 25 to 79 years
- Conditions the study is for
- Aphakia Due to Trauma, Eye; Rupture, Traumatic, With Loss of Intraocular Tissue, Aniridia
- How many people
- 14 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2006to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients
Who may be able to join
- post-traumatic complete aniridia and aphakia
Who cannot join
- active ocluar inflammation or infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- aphakia, black diaphragmintraocular lens, eye rupture, aniridia
- Medical subject headings
- Rupture, Aniridia, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
The visual acuity measurement with ETDRS chart
Measured: 10 to 120 months
The slit lamp examination
The anterior segment of the eye and eye fundus were examined.
Measured: 10 to 120 months
The intrraocular pressure measurement
The procedure was performed with the Goldman applanation tonometer.
Measured: 10 to 120 months
The medical history
Coexisting eye diseases and post-operative complications were noted.
Measured: 10 to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Jan 2006
- Primary completion31 Dec 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia Due to TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominika Nowakowska, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581864
- Sponsor's protocol ID
- 0002
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
- ClinicalTrials.gov ID
- NCT03581864
- Acronym / sponsor ID
- 0002
- Keywords
- aphakia, black diaphragmintraocular lens, eye rupture, aniridia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients
Key inclusion criteria (1 listed)
- post-traumatic complete aniridia and aphakia
Key exclusion criteria (1 listed)
- active ocluar inflammation or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphakia Due to Trauma and Eye; Rupture, Traumatic, With Loss of Intraocular Tissue, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: 10 to 120 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.