MyopiaNCT00347451
Optical Coherence Tomography Imaging of the Posterior Segment in High Myopia.
An observational study of Myopia and Maculopathy, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in the world, with estimates ranging from 30-70% of the general population. Up to 30% of these are high myopes. High myopia is associated with degenerative changes in the fundus. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Maculopathy, Glaucoma
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2005to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Myopic subjects
Who may be able to join
- Healthy young adult males with myopia <-8D
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in the world, with estimates ranging from 30-70% of the general population. Up to 30% of these are high myopes. High myopia is associated with degenerative changes in the fundus. It may also be associated with vision-threatening complications such as macular holes. The pathogenesis of macular holes in high myopes is not completely understood but is postulated to include a combination of anterior vitreous traction and posterior staphyloma formation and axial elongation. These forces lead to degenerative changes at the macula, including foveal detachment and retinoschisis that precede the formation of lamellar or full thickness macular holes. These changes are difficult to detect either clinically or by conventional imaging such as ultrasound, making efforts to correct them in the early stages with surgery difficult. High myopia is also associated with a two- to threefold increase in risk of developing glaucoma. However, the diagnosis of glaucoma in high myopes is difficult as many of the pathological changes in the myopic eye mimic those seen in glaucoma. The myopic optic disc in particular is notoriously difficult to differentiate from the glaucomatous disc. Currently, the diagnosis is highly subjective, relying on observations of the clinical appearance of the disc or on disc photos.Optical coherence tomography (OCT) is an evolving technology that relies on time delays of reflected or backscattered light and interferometry to yield cross-sectional images of the retina and optic disc. The Stratus OCT is the latest model and has been demonstrated to be able to yield images with a resolution comparable to that of histology. It is thus potentially useful in assessing degenerative changes occurring in the myopic fundus, in evaluating the early changes preceding macular hole formation, and in providing objective measures of various disc parameters to aid in diagnosing glaucoma in high myopes. This study aims to recruit 150 healthy, young, ophthalmologically normal males from the SAF and to examine them with OCT. High myopes (≤-8D) will be selected and compared with a control group of low myopes. The performance of the OCT will be evaluated against current diagnostic methods.
Read the detailed description
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.
- Conditions
- Myopia, Maculopathy, Glaucoma
- Keywords
- myopia, optical coherence tomography
- Medical subject headings
- Myopia, Macular Degeneration, Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Laurence S Lim, MBBS, Principal investigator, Singapore National Eye CentreTin Aung, PhD, Study director, Singapore National Eye CentreBobby C Cheng, FRCS, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347451
- Sponsor's protocol ID
- R415/10/2005
- Status last verified
- May 2010
- First submitted
- 30 Jun 2006
- Last updated
- 12 May 2010
- Results posted
- No
Publications
Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.
PubMed 10937558Tay 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.
PubMed 1295418Quek 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.
PubMed 14687201Woo WW, Lim KA, Yang H, Lim XY, Liew F, Lee YS, Saw SM. Refractive errors in medical students in Singapore. Singapore Med J. 2004 Oct;45(10):470-4.
PubMed 15455167Phillips CI, Dobbie JG. Posterior Staphyloma and Retinal Detachment. Am J Ophthalmol. 1963 Feb;55:332-5. doi: 10.1016/0002-9394(63)92692-8. No abstract available.
PubMed 13943139Siam 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.
PubMed 5775575Akiba J, Konno S, Yoshida A. Retinal detachment associated with a macular hole in severely myopic eyes. Am J Ophthalmol. 1999 Nov;128(5):654-5. doi: 10.1016/s0002-9394(99)00240-8.
PubMed 10577545Kishi 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.
PubMed 8909201Ripandelli G, Parisi V, Friberg TR, Coppe AM, Scassa C, Stirpe M. Retinal detachment associated with macular hole in high myopia: using the vitreous anatomy to optimize the surgical approach. Ophthalmology. 2004 Apr;111(4):726-31. doi: 10.1016/j.ophtha.2003.08.026.
PubMed 15051205Ishida 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.
PubMed 10783951Ichibe 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.
PubMed 12888050Hee MR, Puliafito CA, Duker JS, Reichel E, Coker JG, Wilkins JR, Schuman JS, Swanson EA, Fujimoto JG. Topography of diabetic macular edema with optical coherence tomography. Ophthalmology. 1998 Feb;105(2):360-70. doi: 10.1016/s0161-6420(98)93601-6.
PubMed 9479300Hee 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.
PubMed 7777274Azzolini 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.
PubMed 11530047Benhamou N, Massin P, Haouchine B, Erginay A, Gaudric A. Macular retinoschisis in highly myopic eyes. Am J Ophthalmol. 2002 Jun;133(6):794-800. doi: 10.1016/s0002-9394(02)01394-6.
PubMed 12036671
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Imaging of the Posterior Segment in High Myopia.
- ClinicalTrials.gov ID
- NCT00347451
- Acronym / sponsor ID
- R415/10/2005
- Conditions
- Myopia, Maculopathy, Glaucoma
- Keywords
- myopia, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of myopia in East Asia and Singapore in particular is amongst the highest in the world, with estimates ranging from 30-70% of the general population. Up to 30% of these are high myopes. High myopia is associated with degenerative changes in the fundus. It may also be associated with vision-threatening complications such as macular holes. The pathogenesis of macular holes in high myopes is not completely understood but is postulated to include a combination of anterior vitreous traction and posterior staphyloma formation and axial elongation. These forces lead to degenerative changes at the macula, including foveal detachment and retinoschisis that precede the formation of lamellar or full thickness macular holes. These changes are difficult to detect either clinically or by conventional imaging such as ultrasound, making efforts to correct them in the early stages with surgery difficult. High myopia is also associated with a two- to threefold increase in risk of developing glaucoma. However, the diagnosis of glaucoma in high myopes is difficult as many of the pathological changes in the myopic eye mimic those seen in glaucoma. The myopic optic disc in particular is notoriously difficult to differentiate from the glaucomatous disc. Currently, the diagnosis is highly subjective, relying on observations of the clinical appearance of the disc or on disc photos.Optical coherence tomography (OCT) is an evolving technology that relies on time delays of reflected or backscattered light and interferometry to yield cross-sectional images of the retina and optic disc. The Stratus OCT is the latest model and has been demonstrated to be able to yield images with a resolution comparable to that of histology. It is thus potentially useful in assessing degenerative changes occurring in the myopic fundus, in evaluating the early changes preceding macular hole formation, and in providing objective measures of various disc parameters to aid in diagnosing glaucoma in high myopes. This study aims to recruit 150 healthy, young, ophthalmologically normal males from the SAF and to examine them with OCT. High myopes (≤-8D) will be selected and compared with a control group of low myopes. The performance of the OCT will be evaluated against current diagnostic methods.
Detailed description
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Myopic subjects
Key inclusion criteria (1 listed)
- Healthy young adult males with myopia <-8D
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Background: PubMed 10937558Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.
- Background: PubMed 1295418Tay 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.
- Background: PubMed 14687201Quek 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.
- Background: PubMed 15455167Woo WW, Lim KA, Yang H, Lim XY, Liew F, Lee YS, Saw SM. Refractive errors in medical students in Singapore. Singapore Med J. 2004 Oct;45(10):470-4.
- Background: PubMed 13943139Phillips CI, Dobbie JG. Posterior Staphyloma and Retinal Detachment. Am J Ophthalmol. 1963 Feb;55:332-5. doi: 10.1016/0002-9394(63)92692-8. No abstract available.
- Background: PubMed 5775575Siam 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.
- Background: PubMed 10577545Akiba J, Konno S, Yoshida A. Retinal detachment associated with a macular hole in severely myopic eyes. Am J Ophthalmol. 1999 Nov;128(5):654-5. doi: 10.1016/s0002-9394(99)00240-8.
- Background: PubMed 8909201Kishi 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.
- Background: PubMed 15051205Ripandelli G, Parisi V, Friberg TR, Coppe AM, Scassa C, Stirpe M. Retinal detachment associated with macular hole in high myopia: using the vitreous anatomy to optimize the surgical approach. Ophthalmology. 2004 Apr;111(4):726-31. doi: 10.1016/j.ophtha.2003.08.026.
- Background: PubMed 10783951Ishida 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.
- Background: PubMed 12888050Ichibe 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.
- Background: PubMed 9479300Hee MR, Puliafito CA, Duker JS, Reichel E, Coker JG, Wilkins JR, Schuman JS, Swanson EA, Fujimoto JG. Topography of diabetic macular edema with optical coherence tomography. Ophthalmology. 1998 Feb;105(2):360-70. doi: 10.1016/s0161-6420(98)93601-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence S Lim, MBBS principal investigator
Singapore National Eye Centre
Tin Aung, PhD study director
Singapore National Eye Centre
Bobby C Cheng, FRCS principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Maculopathy, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00347451, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.