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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01298895
Other study ID # 0192/09.01.2009.
Secondary ID
Status Completed
Phase N/A
First received February 17, 2011
Last updated February 17, 2011
Start date January 2009
Est. completion date July 2009

Study information

Verified date January 2009
Source General Hospital Sveti Duh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Croatia General Hospital Sveti Duh Zagreb

Sponsors (1)

Lead Sponsor Collaborator
General Hospital Sveti Duh

Country where clinical trial is conducted

Croatia, 

References & Publications (31)

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Bartholomew RS. Anterior chamber depth in eyes with pseudoexfoliation. Br J Ophthalmol. 1980 May;64(5):322-3. — View Citation

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Bjeloš Roncevic M, Bušic M, Cima I, Kuzmanovic Elabjer B, Bosnar D, Miletic D. Comparison of optical low-coherence reflectometry and applanation ultrasound biometry on intraocular lens power calculation. Graefes Arch Clin Exp Ophthalmol. 2011 Jan;249(1):69-75. doi: 10.1007/s00417-010-1509-4. Epub 2010 Sep 18. — View Citation

Bjeloš Roncevic M, Bušic M, Cima I, Kuzmanovic Elabjer B, Bosnar D, Miletic D. Intraobserver and interobserver repeatability of ocular components measurement in cataract eyes using a new optical low coherence reflectometer. Graefes Arch Clin Exp Ophthalmol. 2011 Jan;249(1):83-7. doi: 10.1007/s00417-010-1546-z. Epub 2010 Oct 28. — View Citation

Buckhurst PJ, Wolffsohn JS, Shah S, Naroo SA, Davies LN, Berrow EJ. A new optical low coherence reflectometry device for ocular biometry in cataract patients. Br J Ophthalmol. 2009 Jul;93(7):949-53. doi: 10.1136/bjo.2008.156554. Epub 2009 Apr 19. — View Citation

Busic M, Kastelan S. Pseudoexfoliation syndrome and cataract surgery by phacoemulsification. Coll Antropol. 2005;29 Suppl 1:163-6. Review. — View Citation

Chen MJ, Liu YT, Tsai CC, Chen YC, Chou CK, Lee SM. Relationship between central corneal thickness, refractive error, corneal curvature, anterior chamber depth and axial length. J Chin Med Assoc. 2009 Mar;72(3):133-7. doi: 10.1016/S1726-4901(09)70038-3. — View Citation

Cruysberg LP, Doors M, Verbakel F, Berendschot TT, De Brabander J, Nuijts RM. Evaluation of the Lenstar LS 900 non-contact biometer. Br J Ophthalmol. 2010 Jan;94(1):106-10. doi: 10.1136/bjo.2009.161729. Epub 2009 Aug 18. — View Citation

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Hoffer KJ, Shammas HJ, Savini G. Comparison of 2 laser instruments for measuring axial length. J Cataract Refract Surg. 2010 Apr;36(4):644-8. doi: 10.1016/j.jcrs.2009.11.007. Erratum in: J Cataract Refract Surg. 2010 Jun;36(6):1066. — View Citation

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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.

Karger RA, Jeng SM, Johnson DH, Hodge DO, Good MS. Estimated incidence of pseudoexfoliation syndrome and pseudoexfoliation glaucoma in Olmsted County, Minnesota. J Glaucoma. 2003 Jun;12(3):193-7. — View Citation

Klein BE, Klein R, Lee KE. Incidence of age-related cataract over a 10-year interval: the Beaver Dam Eye Study. Ophthalmology. 2002 Nov;109(11):2052-7. — View Citation

Küchle M, Viestenz A, Martus P, Händel A, Jünemann A, Naumann GO. Anterior chamber depth and complications during cataract surgery in eyes with pseudoexfoliation syndrome. Am J Ophthalmol. 2000 Mar;129(3):281-5. — View Citation

Lanzl IM, Merté RL, Graham AD. Does head positioning influence anterior chamber depth in pseudoexfoliation syndrome? J Glaucoma. 2000 Jun;9(3):214-8. — View Citation

Liampa Z, Kynigopoulos M, Pallas G, Gerding H. Comparison of two partial coherence interferometry devices for ocular biometry. Klin Monbl Augenheilkd. 2010 Apr;227(4):285-8. doi: 10.1055/s-0029-1245182. Epub 2010 Apr 20. — View Citation

Mccarty CA, Taylor HR. Pseudoexfoliation syndrome in Australian adults. Am J Ophthalmol. 2000 May;129(5):629-33. — View Citation

Mohamed NY, Hassan MN, Ali NA, Binnawi KH. Central Corneal Thickness in Sudanese Population. Sud J Ophthalmol 1:29-32, 2009.

Naseem A. Cataract surgery in patients with pseudoexfoliation. [Dissertation]. Karachi: College of Physicians & Surgeons :111, 2002.

Oliveira C, Tello C, Liebmann J, Ritch R. Central corneal thickness is not related to anterior scleral thickness or axial length. J Glaucoma. 2006 Jun;15(3):190-4. — View Citation

Prince AM, Ritch R. Clinical signs of the pseudoexfoliation syndrome. Ophthalmology. 1986 Jun;93(6):803-7. — View Citation

Repo LP, Naukkarinen A, Paljärvi L, Teräsvirta ME. Pseudoexfoliation syndrome with poorly dilating pupil: a light and electron microscopic study of the sphincter area. Graefes Arch Clin Exp Ophthalmol. 1996 Mar;234(3):171-6. — View Citation

Rohrer K, Frueh BE, Wälti R, Clemetson IA, Tappeiner C, Goldblum D. Comparison and evaluation of ocular biometry using a new noncontact optical low-coherence reflectometer. Ophthalmology. 2009 Nov;116(11):2087-92. doi: 10.1016/j.ophtha.2009.04.019. Epub 2009 Sep 10. — View Citation

Salzmann M. The Anatomy and Histology of the Human Eyeball , trans. E. V. L. Brown. University of Chicago Press, Chicago, 1912.

Scorolli L, Scorolli L, Campos EC, Bassein L, Meduri RA. Pseudoexfoliation syndrome: a cohort study on intraoperative complications in cataract surgery. Ophthalmologica. 1998;212(4):278-80. — View Citation

Shah S, Chatterjee A, Mathai M, Kelly SP, Kwartz J, Henson D, McLeod D. Relationship between corneal thickness and measured intraocular pressure in a general ophthalmology clinic. Ophthalmology. 1999 Nov;106(11):2154-60. — View Citation

Suzuki R, Kurimoto S. Intraocular muscle function in pseudoexfoliation syndrome. Ophthalmologica. 1992;204(4):192-8. — View Citation

Yülek F, Konukseven OO, Cakmak HB, Orhan N, Simsek S, Kutluhan A. Comparison of the pupillometry during videonystagmography in asymmetric pseudoexfoliation patients. Curr Eye Res. 2008 Mar;33(3):263-7. doi: 10.1080/02713680801915284. — View Citation

* Note: There are 31 references in allClick here to view all references

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