- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00347451
Optical Coherence Tomography Imaging of the Posterior Segment in High Myopia.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Primary AimThe aim of the study is to evaluate the retinal and macular topography, vitreomacular relationships and optic nerve head changes in highly myopic eyes of young adults. Specific aims include:1) To determine the prevalence of vitreo-macular traction and macular degenerations (macular thickening, detachments, schisis or lamellar holes) in asymptomatic, highly myopic young Asian males using OCT.2) To characterize and measure optic nerve head and peripapillary retinal nerve fibre layer changes in high myopia using OCT.3) To compare OCT findings with current methods of investigation and diagnosis
SubjectsSubjects will be drawn from in-service personnel as well as recruits awaiting enlistment. They will be identified based on their refraction through the SAF's computerized medical records system.Informed consent will be sought from the subjects before commencement. All subjects will be healthy young males and will be ophthalmologically normal apart from myopia. The main exclusion criteria are:1) Best corrected visual acuity <6/92) Previous intraocular surgery3) Intraocular pressure >21mmHg4) Gonioscopic findings of angle closure5) Clinical evidence of pseudo-exfoliation, uveitis or pigment dispersion syndrome, corneal or media opacities, retinal pathology or neurological diseases6) Family history in a first degree relative of glaucoma or other optic neuropathy.Excluded subjects will be replaced by the subject next-in-line in the cohort.ProcedureAll subjects identified will be examined at SNEC/SERI by one of the investigators. The assessment for each subject will include:1) Autorefraction performed with a non-accommodating target and recording of best corrected visual acuity. 2) Slit lamp examination, Goldmann applanation tonometry, gonioscopy, examination with a Goldmann three-mirror lens, and a dilated fundus examination with a 78 diopter fundus lens. Retinal findings are recorded in standard Amsler Dubois retinal diagrams. Grading of background myopic chorioretinal changes will be in accordance with the scheme proposed by Avila . 3) Axial length measurements. Ultrasound A scan is performed for each eye. Axial length is ascertained from the average of six consistent recordings. Care is taken to locate the fovea especially in cases with posterior staphyloma, by ensuring fixation of the A scan probe light. 4) Fundus photography with the Topcon camera. Stereoscopic disc photographs will also be taken for comparison with OCT scans of the optic nerve head.5) OCT using the Stratus OCTOCT measurements will be performed at one sitting by a trained technician. The commercially prescribed Optic Disc, RNFL and Macular Thickness scanning algorithms will be used. Each subject will fixate on an internal target presented by the computer where possible, or an external fixation target for cases unable to cooperate. Subjects will be encouraged to blink between the acquisition of each radial scan to minimize discomfort and minimize the effect of an irregular tear film or corneal desiccation on the tear film. Each scan will take approximately 2.5s, making for a total image acquisition time of less than a minute. The optic nerve head scan consists of six radial scans centered on the optic nerve head. The computer generated disc margin will be used as the reference for optic nerve head measurements. The macular thickness protocol uses six radial scans centered on the fovea. The retinal thickness is measured automatically as the distance between the vitreoretinal interface and the junction between the inner and outer segments of photoreceptors.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
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Singapore, Singapore, 168751
- Singapore National Eye Centre
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Healthy young adult males with myopia <-8D
Exclusion Criteria:
- Best corrected visual acuity <6/9
- Previous intraocular surgery
- Intraocular pressure >21mmHg
- Gonioscopic findings of angle closure
- Clinical evidence of pseudo-exfoliation, uveitis or pigment dispersion syndrome, corneal or media opacities, retinal pathology or neurological diseases
- Family history in a first degree relative of glaucoma or other optic neuropathy.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Laurence S Lim, MBBS, Singapore National Eye Centre
- Opintojohtaja: Tin Aung, PhD, Singapore National Eye Centre
- Päätutkija: Bobby C Cheng, FRCS, Singapore National Eye Centre
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
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- Tay MT, Au Eong KG, Ng CY, Lim MK. Myopia and educational attainment in 421,116 young Singaporean males. Ann Acad Med Singap. 1992 Nov;21(6):785-91.
- Quek TP, Chua CG, Chong CS, Chong JH, Hey HW, Lee J, Lim YF, Saw SM. Prevalence of refractive errors in teenage high school students in Singapore. Ophthalmic Physiol Opt. 2004 Jan;24(1):47-55. doi: 10.1046/j.1475-1313.2003.00166.x.
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- PHILLIPS CI, DOBBIE JG. Posterior staphyloma and retnal detachment. Am J Ophthalmol. 1963 Feb;55:332-5. doi: 10.1016/0002-9394(63)92692-8. No abstract available.
- Siam A. Macular hole with central retinal detachment in high myopia with posterior staphyloma. Br J Ophthalmol. 1969 Jan;53(1):62-3. doi: 10.1136/bjo.53.1.62. No abstract available.
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- Kishi S, Hagimura N, Shimizu K. The role of the premacular liquefied pocket and premacular vitreous cortex in idiopathic macular hole development. Am J Ophthalmol. 1996 Nov;122(5):622-8. doi: 10.1016/s0002-9394(14)70480-5.
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- Ishida S, Yamazaki K, Shinoda K, Kawashima S, Oguchi Y. Macular hole retinal detachment in highly myopic eyes: ultrastructure of surgically removed epiretinal membrane and clinicopathologic correlation. Retina. 2000;20(2):176-83.
- Ichibe M, Yoshizawa T, Murakami K, Ohta M, Oya Y, Yamamoto S, Funaki S, Funaki H, Ozawa Y, Baba E, Abe H. Surgical management of retinal detachment associated with myopic macular hole: anatomic and functional status of the macula. Am J Ophthalmol. 2003 Aug;136(2):277-84. doi: 10.1016/s0002-9394(03)00186-7.
- Hee MR, Puliafito CA, Wong C, Duker JS, Reichel E, Schuman JS, Swanson EA, Fujimoto JG. Optical coherence tomography of macular holes. Ophthalmology. 1995 May;102(5):748-56. doi: 10.1016/s0161-6420(95)30959-1.
- Azzolini C, Patelli F, Brancato R. Correlation between optical coherence tomography data and biomicroscopic interpretation of idiopathic macular hole. Am J Ophthalmol. 2001 Sep;132(3):348-55. doi: 10.1016/s0002-9394(01)01005-4.
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- Jonas JB, Gusek GC, Naumann GO. Optic disk morphometry in high myopia. Graefes Arch Clin Exp Ophthalmol. 1988;226(6):587-90. doi: 10.1007/BF02169209.
- Jonas JB, Dichtl A. Optic disc morphology in myopic primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 1997 Oct;235(10):627-33. doi: 10.1007/BF00946938.
- Dichtl A, Jonas JB, Naumann GO. Histomorphometry of the optic disc in highly myopic eyes with absolute secondary angle closure glaucoma. Br J Ophthalmol. 1998 Mar;82(3):286-9. doi: 10.1136/bjo.82.3.286.
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- Schuman JS, Wollstein G, Farra T, Hertzmark E, Aydin A, Fujimoto JG, Paunescu LA. Comparison of optic nerve head measurements obtained by optical coherence tomography and confocal scanning laser ophthalmoscopy. Am J Ophthalmol. 2003 Apr;135(4):504-12. doi: 10.1016/s0002-9394(02)02093-7. Erratum In: Am J Ophthalmol. 2003 Aug;136(2):following 403.
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- Avila MP, Weiter JJ, Jalkh AE, Trempe CL, Pruett RC, Schepens CL. Natural history of choroidal neovascularization in degenerative myopia. Ophthalmology. 1984 Dec;91(12):1573-81. doi: 10.1016/s0161-6420(84)34116-1.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- R415/10/2005
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