CataractQu01NCT01244373
A Prospective Observational Case Series of a Four-ring-haptic Acrylic One-piece IOL
An observational study of Cataract, run by General Hospital Linz at 1 site in Austria.
Trial summary
To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- How many people
- 9 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to Aug 2009
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced age-related cataract and indication for phacoemuslification of the lens with following implantation of an intraocular lens (posterior chamber)
Who may be able to join
- Patients with senile cortico-nuclear cataracts without previous intraocular surgery
Who cannot join
- Dilated pupil size of < 6 mm
- long-term anti-inflammatory treatment
- previous history of intraocular surgery
- previous history of corneal endothelial damage
- previous history of ocular trauma
- traumatic cataract
Show all 9Show fewer
- history of uveitis
- diabetic retinopathy
- advanced macular degeneration
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of ophthalmology, General Hospital Linz
Linz, Upper Austria, 4021
About this study
Official title: Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".
To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.
Read the detailed description
In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of nine patients with senile cortico-nuclear cataract. A standardized surgical technique and post-operative regimen were applied. Six months postoperatively best corrected visual acuity (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were analysed.
- Conditions
- Cataract
- Keywords
- Best-corrected visual acuity, posterior capsule opacification, QUATRIX® Aspheric Evolutive pre-loaded
- Medical subject headings
- Cataract
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 |
|---|---|---|
| Patients with senile cataract | Patients with senile cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
The best-corrected visual acuity is assessed with glasses after cataract operation
Measured: Six months
Secondary outcomes (1)
Posterior capsule opacification
The posterior capsule opacification is assessed by slit lamp examination and subjective grading
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startMay 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Department of ophthalmology, General Hospital Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244373
- Sponsor's protocol ID
- Quatrix01
- Acronym
- Qu01
- Status last verified
- Nov 2010
- First submitted
- 18 Nov 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer S, Schroder AC, Bruckner K, Jonescu-Cuypers C, Seitz B. [Subluxation of hydrophilic acrylate intraocular lenses due to massive capsular fibrosis]. Ophthalmologe. 2010 May;107(5):460-4. doi: 10.1007/s00347-009-2025-y. German.
PubMed 19756637Michael K, O'Colmain U, Vallance JH, Cormack TG. Capsule contraction syndrome with haptic deformation and flexion. J Cataract Refract Surg. 2010 Apr;36(4):686-9. doi: 10.1016/j.jcrs.2009.09.042.
PubMed 20362866
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Case Series of the Implantation of Intraocular Lens "QUATRIX® Aspheric Evolutive Pre-loaded".
- ClinicalTrials.gov ID
- NCT01244373
- Acronym / sponsor ID
- Qu01 / Quatrix01
- Conditions
- Cataract
- Keywords
- Best-corrected visual acuity, posterior capsule opacification, QUATRIX® Aspheric Evolutive pre-loaded
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- General Hospital LinzUniversity, hospital or other
- Collaborators
- Department of ophthalmology, General Hospital Linz
- Study start
- May 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Nov 2010 (estimated)
- 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.
To describe biocompatibility, postoperative results and complications after implantation of the Corneal Quatrix Evolutive (Corneal, Croma, Austria) intraocular lens, a hydrophilic acrylic intraocular lens (IOL) with 4-haptic design and 360° sharp optic edge.
Detailed description
In this prospective case series the Corneal Quatrix Evolutive IOL was implanted in 14 eyes of nine patients with senile cortico-nuclear cataract. A standardized surgical technique and post-operative regimen were applied. Six months postoperatively best corrected visual acuity (BCVA), refraction and complications (especially) posterior capsule opacification (PCO) were analysed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with senile cataract | – | –Patients with senile cataract |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced age-related cataract and indication for phacoemuslification of the lens with following implantation of an intraocular lens (posterior chamber)
Key inclusion criteria (1 listed)
- Patients with senile cortico-nuclear cataracts without previous intraocular surgery
Key exclusion criteria (9 listed)
- Dilated pupil size of < 6 mm
- long-term anti-inflammatory treatment
- previous history of intraocular surgery
- previous history of corneal endothelial damage
- previous history of ocular trauma
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 (BCVA)
Time frame: Six months
The best-corrected visual acuity is assessed with glasses after cataract operation
1 secondary outcome
Posterior capsule opacification
Time frame: Six months
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 19 Nov 2010.
- Background: PubMed 19756637Kramer S, Schroder AC, Bruckner K, Jonescu-Cuypers C, Seitz B. [Subluxation of hydrophilic acrylate intraocular lenses due to massive capsular fibrosis]. Ophthalmologe. 2010 May;107(5):460-4. doi: 10.1007/s00347-009-2025-y. German.
- Background: PubMed 20362866Michael K, O'Colmain U, Vallance JH, Cormack TG. Capsule contraction syndrome with haptic deformation and flexion. J Cataract Refract Surg. 2010 Apr;36(4):686-9. doi: 10.1016/j.jcrs.2009.09.042.
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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 Cataract, run by General Hospital Linz at 1 site in Austria.
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 9 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 19 Nov 2010. 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 Austria. 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 (BCVA) (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244373, which also lists 2 linked publications.
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 19 Nov 2010.