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

NCT ID: NCT01298895

Last Updated: 2011-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-07-31

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.

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.

Conditions

Pseudoexfoliation Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PEX group

The first group consisted of 47 eyes with cataract complicated with pseudoexfoliation syndrome (PEX).

No interventions assigned to this group

control group

The control group included 177 eyes with uncomplicated cataract in eyes without other ocular pathology

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital Sveti Duh

OTHER

Sponsor Role: lead

Responsible Party

Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia

Principal Investigators

Mladen Bušić, Assoc.Prof.

Role: STUDY_DIRECTOR

University Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia

Locations

General Hospital Sveti Duh

Zagreb, , Croatia

Countries

Croatia

References

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

Reference Type: BACKGROUND

PMID: 16193703 (View on PubMed)

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. doi: 10.1159/000027307.

Reference Type: BACKGROUND

PMID: 9672219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19380310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19692383 (View on PubMed)

Rohrer K, Frueh BE, Walti 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.

Reference Type: BACKGROUND

PMID: 19744720 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20362858 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20408075 (View on PubMed)

Bjelos Roncevic M, Busic 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.

Reference Type: BACKGROUND

PMID: 20853004 (View on PubMed)

Bjelos Roncevic M, Busic 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.

Reference Type: BACKGROUND

PMID: 20981435 (View on PubMed)

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. doi: 10.1097/00061198-200306000-00002.

Reference Type: BACKGROUND

PMID: 12782834 (View on PubMed)

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. doi: 10.1016/s0161-6420(02)01249-6.

Reference Type: BACKGROUND

PMID: 12414414 (View on PubMed)

Mccarty CA, Taylor HR. Pseudoexfoliation syndrome in Australian adults. Am J Ophthalmol. 2000 May;129(5):629-33. doi: 10.1016/s0002-9394(99)00466-3.

Reference Type: BACKGROUND

PMID: 10844055 (View on PubMed)

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.

Reference Type: BACKGROUND

Bartholomew RS. Anterior chamber depth in eyes with pseudoexfoliation. Br J Ophthalmol. 1980 May;64(5):322-3. doi: 10.1136/bjo.64.5.322.

Reference Type: BACKGROUND

PMID: 7437392 (View on PubMed)

Kuchle M, Viestenz A, Martus P, Handel A, Junemann 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. doi: 10.1016/s0002-9394(99)00365-7.

Reference Type: BACKGROUND

PMID: 10704540 (View on PubMed)

Jünemann A, Martus P, Händel A, Naumann GOH. Ocular dimensions in pseudoexfoliation syndrome. Ophthalmic Res 29:88, 1997.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Lanzl IM, Merte RL, Graham AD. Does head positioning influence anterior chamber depth in pseudoexfoliation syndrome? J Glaucoma. 2000 Jun;9(3):214-8. doi: 10.1097/00061198-200006000-00003.

Reference Type: BACKGROUND

PMID: 10877371 (View on PubMed)

Arnarsson A, Damji KF, Sverrisson T, Sasaki H, Jonasson F. Pseudoexfoliation in the Reykjavik Eye Study: prevalence and related ophthalmological variables. Acta Ophthalmol Scand. 2007 Dec;85(8):822-7. doi: 10.1111/j.1600-0420.2007.01051.x.

Reference Type: BACKGROUND

PMID: 18028119 (View on PubMed)

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

Reference Type: BACKGROUND

Suzuki R, Kurimoto S. Intraocular muscle function in pseudoexfoliation syndrome. Ophthalmologica. 1992;204(4):192-8. doi: 10.1159/000310293.

Reference Type: BACKGROUND

PMID: 1513550 (View on PubMed)

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

Reference Type: BACKGROUND

Yulek 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.

Reference Type: BACKGROUND

PMID: 18350437 (View on PubMed)

Repo LP, Naukkarinen A, Paljarvi L, Terasvirta 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. doi: 10.1007/BF00462029.

Reference Type: BACKGROUND

PMID: 8720716 (View on PubMed)

Prince AM, Ritch R. Clinical signs of the pseudoexfoliation syndrome. Ophthalmology. 1986 Jun;93(6):803-7. doi: 10.1016/s0161-6420(86)33664-9.

Reference Type: BACKGROUND

PMID: 3737125 (View on PubMed)

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

Reference Type: BACKGROUND

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. doi: 10.1097/01.ijg.0000212220.42675.c5.

Reference Type: BACKGROUND

PMID: 16778639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19299220 (View on PubMed)

Hepsen IF, Yagci R, Keskin U. Corneal curvature and central corneal thickness in eyes with pseudoexfoliation syndrome. Can J Ophthalmol. 2007 Oct;42(5):677-80. doi: 10.3129/i07-145.

Reference Type: BACKGROUND

PMID: 17891195 (View on PubMed)

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. doi: 10.1016/S0161-6420(99)90498-0.

Reference Type: BACKGROUND

PMID: 10571352 (View on PubMed)

Ganguli D, Roy IS, Biswas SK, Sengupta M. Study of corneal power and diameter in simple refractive error. Indian J Ophthalmol. 1975 Apr;23(1):6-11. No abstract available.

Reference Type: BACKGROUND

PMID: 1158423 (View on PubMed)

Other Identifiers

0192/09.01.2009.

Identifier Type: -

Identifier Source: org_study_id