Pseudoexfoliation Syndrome in Cataract Myopic EyesNCT01637740
Pseudoexfoliation Syndrome in Myopes
An observational study of Pseudoexfoliation Syndrome in Cataract Myopic Eyes, run by General Hospital Sveti Duh.
Trial summary
A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pseudoexfoliation Syndrome in Cataract Myopic Eyes
- How many people
- 5,753 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jan 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5753 eyes of cataract surgery patients ≥ 40 years old
Who may be able to join
- cataract surgery patients ≥ 40 years old
Who cannot join
- cataract surgery patients < 40 years old
About this study
Official title: Pseudoexfoliation Syndrome in Myopes Defined With Optical Low Coherence Reflectometry
A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.
Read the detailed description
A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.
- Keywords
- myopia, pseudoexfoliation syndrome, optical low coherence reflectometry, ocular optical components, cataract
- Medical subject headings
- Myopia, Exfoliation Syndrome, 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 |
|---|---|---|
| eyes with pseudoexfoliation syndrome | cataract myopic eyes with pseudoexfoliation syndrome | |
| eyes without pseudoexfoliation syndrome | cataract myopic eyes without pseudoexfoliation syndrome |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation Syndrome in Cataract Myopic EyesStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 5,753 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mladen Busic, General Hospital Sveti Duh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637740
- Sponsor's protocol ID
- 04072012MB
- Other IDs
- 04072012UECUHSD
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoexfoliation Syndrome in Myopes Defined With Optical Low Coherence Reflectometry
- ClinicalTrials.gov ID
- NCT01637740
- Acronym / sponsor ID
- 04072012MB
- Keywords
- myopia, pseudoexfoliation syndrome, optical low coherence reflectometry, ocular optical components, cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,753 participants (actual)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Jul 2012 (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.
A retrospective study of 5753 eyes of cataract surgery patients was conducted at our Clinic. Ocular optical components measured by optical low coherence reflectometry biometer LENSTAR LS 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.
Detailed description
A retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators Clinic in a period of 2.5 years. Pseudoexfoliation syndrome was found in 255 eyes. There were only 26 cataract myopic eyes with pseudoexfoliation syndrome. Refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (IOL) value done by optical low coherence reflectometry biometer LENSTAR LS 900®. Ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization IOL value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eyes with pseudoexfoliation syndrome | – | –cataract myopic eyes with pseudoexfoliation syndrome |
| eyes without pseudoexfoliation syndrome | – | –cataract myopic eyes without pseudoexfoliation syndrome |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5753 eyes of cataract surgery patients ≥ 40 years old
Key inclusion criteria (1 listed)
- cataract surgery patients ≥ 40 years old
Key exclusion criteria (1 listed)
- cataract surgery patients < 40 years old
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
Not reported in the source record.
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 11 Jul 2012.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome in Cataract Myopic Eyes, run by General Hospital Sveti Duh.
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 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 11 Jul 2012.