NCT01298895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
Last Updated

February 18, 2011

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

February 17, 2011

Last Update Submit

February 17, 2011

Conditions

Pseudoexfoliation Syndrome

Keywords

optical componentspseudoexfoliationcataractLENSTAR® LS 900®

Study Arms (2)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Sveti Duh

Zagreb, 10 000, Croatia

Location

Related Publications (31)

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

    PMID: 16193703BACKGROUND

  • 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.

    PMID: 9672219BACKGROUND

  • 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.

    PMID: 19380310BACKGROUND

  • 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.

    PMID: 19692383BACKGROUND

  • 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.

    PMID: 19744720BACKGROUND

  • 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.

    PMID: 20362858BACKGROUND

  • 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.

    PMID: 20408075BACKGROUND

  • 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.

    PMID: 20853004BACKGROUND

  • 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.

    PMID: 20981435BACKGROUND

  • 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.

    PMID: 12782834BACKGROUND

  • 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.

    PMID: 12414414BACKGROUND

  • 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.

    PMID: 10844055BACKGROUND

  • 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.

    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.

    PMID: 7437392BACKGROUND

  • 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.

    PMID: 10704540BACKGROUND

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

    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.

    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.

    PMID: 10877371BACKGROUND

  • 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.

    PMID: 18028119BACKGROUND

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

    BACKGROUND

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

    PMID: 1513550BACKGROUND

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

    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.

    PMID: 18350437BACKGROUND

  • 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.

    PMID: 8720716BACKGROUND

  • 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.

    PMID: 3737125BACKGROUND

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

    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.

    PMID: 16778639BACKGROUND

  • 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.

    PMID: 19299220BACKGROUND

  • 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.

    PMID: 17891195BACKGROUND

  • 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.

    PMID: 10571352BACKGROUND

  • 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.

    PMID: 1158423BACKGROUND

MeSH Terms

Conditions

Exfoliation SyndromeCataract

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye DiseasesLens Diseases

Study Officials

  • Mladen Bušić, Assoc.Prof.

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 18, 2011

Record last verified: 2009-01

Locations

CR(1)