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Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome

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ClinicalTrials.gov Identifier: NCT01298895
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study was to evaluate optical ocular components in patients with pseudoexfoliation syndrome using optical low coherence reflectometry. A prospective cohort study of 224 eyes of patients planned for cataract surgery was conducted from January 2009 until July 2009. Patients were divided in two groups: the first group of 47 eyes with cataract complicated with pseudoexfoliation syndrome and the control group of 177 eyes with uncomplicated cataract. Each group was further divided into two subgroups based on its refractive state: emmetropes and hypermetropes. The optical low coherence reflectometry biometer LENSTAR® LS 900® was used to define ocular optical components.

Condition or disease
Pseudoexfoliation Syndrome

Detailed Description:
Material and methods A prospective cohort study of 224 eyes of patients planned for cataract surgery was conducted at the University Eye Clinic, General Hospital Sveti Duh, Zagreb, Croatia. The inclusion criteria was age of patients over 40 years. Sex and refractive eye state were randomly chosen out of all cataract patients operated at the Clinic from January 2009 until July 2009. Patients were divided in two groups. The first group consisted of 47 eyes with cataract complicated with PEX. The control group included 177 eyes with uncomplicated cataract in eyes without other ocular pathology. Refractive state was defined by preoperatively calculated emmetropisation intraocular lens (IOL) value done by LENSTAR LS 900®. Emmetropes had IOL value of 20-22 diopters and hypermetropes of more than 22 diopters. There were no myopic patients defined as IOL value less than 20 diopters in the PEX group operated at the Clinic in the defined time. Consequently, there were no myopic patients included in the control group. The PEX group and the control group were further divided into two subgroups: emmetropes and hypermetropes. LENSTAR LS 900® was used to measure ocular optical components 3-9: axial length (AL), central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), retinal thickness (RT), keratometry values (keratometry of the steepest meridian (K1), keratometry of the flattest meridian (K2), its position regarding horizontal line (AXIS) and the difference between K1 and K2 (astigmatism, AST), horizontal diameter of iris (WTW) and pupillary diameter (PD). Ethics committee approval of General Hospital Sveti Duh, Zagreb, Croatia, was secured for the study reported. All study procedures adhered to the recommendations of the Declaration of Helsinki. Written consent was obtained from all patients prior to their inclusion in the study. Sample size was defined in a way to provide sufficient statistical power of the study, which was in this case over 90%. Descriptive statistics and Student's t-test were used for data evaluation. Value of p<0.05 was considered significant.

Study Design

Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome
Study Start Date : January 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort
PEX group
The first group consisted of 47 eyes with cataract complicated with pseudoexfoliation syndrome (PEX).
control group
The control group included 177 eyes with uncomplicated cataract in eyes without other ocular pathology


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A prospective cohort study of 224 eyes of patients planned for cataract surgery was conducted at the University Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia. The inclusion criteria was age of patients over 40 years. Sex and refractive eye state were randomly chosen out of all cataract patients operated at the Clinic from January 2009 until July 2009.
Criteria

Inclusion Criteria:

  • age of patients over 40 years old
  • must have cataract
  • for the PEX group must have cataract complicated with PEX

Exclusion criteria:

  • age below 40 years old
  • absence of cataract
  • presence of other ocular pathology in the control group
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298895


Locations
Croatia
General Hospital Sveti Duh
Zagreb, Croatia, 10 000
Sponsors and Collaborators
General Hospital Sveti Duh
Investigators
Study Director: Mladen Bušić, Assoc.Prof. University Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia
More Information

Publications:
Bayramlar H, Ozden S, Ergin M, Tutarli H. Ultrasonografic measurement of ocular refractive components in eyes with various refractive states. T Klin Oftalmoloji 3:90-94, 1994.
Jünemann A, Martus P, Händel A, Naumann GOH. Ocular dimensions in pseudoexfoliation syndrome. Ophthalmic Res 29:88, 1997.
Kaneda J, Sasaki H, Nagai K, Fujisawa A, Kawakami Y, Sakamoto A, N Takahashi N, Sasaki K. Forward Malposition of the Crystalline Lens in Pseudoexfoliation Syndrome. Invest Ophthalmol Vis Sci 43, 2002.
Salzmann M. The Anatomy and Histology of the Human Eyeball , trans. E. V. L. Brown. University of Chicago Press, Chicago, 1912.
Naseem A. Cataract surgery in patients with pseudoexfoliation. [Dissertation]. Karachi: College of Physicians & Surgeons :111, 2002.
Mohamed NY, Hassan MN, Ali NA, Binnawi KH. Central Corneal Thickness in Sudanese Population. Sud J Ophthalmol 1:29-32, 2009.

Responsible Party: Damir Bosnar, PhD, Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia
ClinicalTrials.gov Identifier: NCT01298895     History of Changes
Other Study ID Numbers: 0192/09.01.2009.
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: January 2009

Keywords provided by General Hospital Sveti Duh:
optical components
pseudoexfoliation
cataract
LENSTAR® LS 900®

Additional relevant MeSH terms:
Syndrome
Exfoliation Syndrome
Disease
Pathologic Processes
Iris Diseases
Uveal Diseases
Eye Diseases