Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 3:44 PM
Study NCT ID:
NCT01298895
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2011-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome
Sponsor:
Organization:
Raw JSON
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Pseudoexfoliation syndrome and cataract surgery by phacoemulsification. Coll Antropol. 2005;29 Suppl 1:163-6.'}, {'pmid': '9672219', 'type': 'BACKGROUND', 'citation': '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': '19380310', 'type': 'BACKGROUND', '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.'}, {'pmid': '19692383', 'type': 'BACKGROUND', '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.'}, {'pmid': '19744720', 'type': 'BACKGROUND', 'citation': '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': '20362858', 'type': 'BACKGROUND', 'citation': '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': '20408075', 'type': 'BACKGROUND', '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.'}, {'pmid': '20853004', 'type': 'BACKGROUND', 'citation': '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': '20981435', 'type': 'BACKGROUND', 'citation': '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': '12782834', 'type': 'BACKGROUND', 'citation': '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': '12414414', 'type': 'BACKGROUND', '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. doi: 10.1016/s0161-6420(02)01249-6.'}, {'pmid': '10844055', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7437392', 'type': 'BACKGROUND', 'citation': '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': '10704540', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Jünemann A, Martus P, Händel A, Naumann GOH. Ocular dimensions in pseudoexfoliation syndrome. Ophthalmic Res 29:88, 1997.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10877371', 'type': 'BACKGROUND', 'citation': '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': '18028119', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Salzmann M. The Anatomy and Histology of the Human Eyeball , trans. E. V. L. Brown. University of Chicago Press, Chicago, 1912.'}, {'pmid': '1513550', 'type': 'BACKGROUND', 'citation': 'Suzuki R, Kurimoto S. Intraocular muscle function in pseudoexfoliation syndrome. Ophthalmologica. 1992;204(4):192-8. doi: 10.1159/000310293.'}, {'type': 'BACKGROUND', 'citation': 'Naseem A. Cataract surgery in patients with pseudoexfoliation. [Dissertation]. Karachi: College of Physicians & Surgeons :111, 2002.'}, {'pmid': '18350437', 'type': 'BACKGROUND', 'citation': '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': '8720716', 'type': 'BACKGROUND', 'citation': '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': '3737125', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Mohamed NY, Hassan MN, Ali NA, Binnawi KH. Central Corneal Thickness in Sudanese Population. Sud J Ophthalmol 1:29-32, 2009.'}, {'pmid': '16778639', 'type': 'BACKGROUND', 'citation': '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': '19299220', 'type': 'BACKGROUND', '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.'}, {'pmid': '17891195', 'type': 'BACKGROUND', 'citation': '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': '10571352', 'type': 'BACKGROUND', '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. doi: 10.1016/S0161-6420(99)90498-0.'}, {'pmid': '1158423', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of patients over 40 years old\n* must have cataract\n* for the PEX group must have cataract complicated with PEX\n\nExclusion criteria:\n\n* age below 40 years old\n* absence of cataract\n* presence of other ocular pathology in the control group'}, 'identificationModule': {'nctId': 'NCT01298895', 'briefTitle': 'Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital Sveti Duh'}, 'officialTitle': 'Optical Low Coherence Reflectometry Enables Preoperative Detection of Zonular Weakness in Pseudoexfoliation Syndrome', 'orgStudyIdInfo': {'id': '0192/09.01.2009.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEX group', 'description': 'The first group consisted of 47 eyes with cataract complicated with pseudoexfoliation syndrome (PEX).'}, {'label': 'control group', 'description': 'The control group included 177 eyes with uncomplicated cataract in eyes without other ocular pathology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'General Hospital Sveti Duh', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Mladen Bušić, Assoc.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital Sveti Duh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Damir Bosnar, PhD', 'oldOrganization': 'Eye Clinic, General hospital Sveti Duh, Zagreb, Croatia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-30', 'type': 'RELEASE'}, {'date': '2011-07-28', 'type': 'RESET'}, {'date': '2011-10-14', 'type': 'RELEASE'}, {'date': '2011-11-18', 'type': 'RESET'}, {'date': '2012-04-06', 'type': 'RELEASE'}, {'date': '2012-04-30', 'type': 'RESET'}, {'date': '2020-02-26', 'type': 'RELEASE'}, {'date': '2020-03-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Damir Bosnar, Assoc. prof., M.D., PhD, General Hospital Sveti Duh'}}}}