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

This study has been completed.
Sponsor:
Information provided by:
General Hospital Sveti Duh
ClinicalTrials.gov Identifier:
NCT01298895
First received: February 17, 2011
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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
Pseudoexfoliation Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome

Resource links provided by NLM:


Further study details as provided by General Hospital Sveti Duh:

Enrollment: 224
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Hoffer KJ, Shammas HJ, Savini G. Comparison of 2 laser instruments for measuring axial length. J Cataract Refract Surg 36:644-648 Erratum in: J Cataract Refract Surg 36:1066, 2010.
Liampa Z, Kynigopoulos M, Pallas G, Gerding H. Comparison of two partial coherence interferometry devices for ocular biometry. Klin Monbl Augenheilkd 227:285-288, 2010.
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.
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.
Study First Received: February 17, 2011
Last Updated: February 17, 2011
Health Authority: Croatia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014