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MyopiaNCT00838734

Compare Anterior Chamber Biometry in Healthy and Post-LASIK Patients

An observational study of Myopia and Astigmatism, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Astigmatism
How many people
100 participants
Where
1 siteTaiwan
Study dates
Jun 2008to Jun 2009
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: Healthy volunteer

Who may be able to join

  • healthy young volunteer who has not received any ocular surgery
  • post-LASIK surgery young volunteers
  • all participants has to be less than 35 years old.

Who cannot join

  • any subject with contact lens history will be asked to stop contact lens wear for at least 4 weeks before participating in this study.
  • any subject with prior ocular disease
  • any subject with prior intra-ocular surgery
  • any subject who cannot cooperate with examination

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Far Eastern Memorial Hospital

    Banqiao District, Taipei, 220

    Shu-Wen Chang, MD, 886-2-8966-7000, swchang@mail.femh.org.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Compare Anterior Chamber Biometry in Healthy and Post-LASIK Pati

In this study, the investigators employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. The investigators hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.

Read the detailed description

Accommodation is an action that enables projections of both distant and near objects to be brought into clear focus on the retina through changing of diopteric power of crystalline lens. Although the exact mechanism of accommodation remains inconclusive, most authors agree that contraction of ciliary muscle plays a pivotal role.1, 2 Recently, accumulating evidence shows that the effect of ciliary muscle contraction goes beyond merely changing the curvature of the crystalline lens.3 Ciliary muscle contraction might be responsible for a transient elongation in axial length during the accommodation response.3 Contraction of ciliary smooth muscle applied an inward pulling force on the choroid and sclera adjacent to the ciliary body and cause protrusion at posterior sclera.

If ciliary muscle contraction can elicit protrusion at posterior sclera, it is conceivable that some changes in corneal shape would also occur as the cornea is adjacent to ciliary muscle. The influence of accommodation on the cornea has therefore been the subject of several studies with conflicting results. Some authors reported no change4, 5, while others described significant change in corneal curvature during accommodation6-9. Yasuda and Yamaguchi9 found central corneal steepening of approximately 0.10 D, using pharmacologically induced ciliary muscle contraction and corneal topography analysis. Saitoh et al10 reported that instillation of a sympathomimetic agent to stimulate mydriasis induces significant flattening of both anterior and posterior cornea curvatures as detected by Orbscan . On the contrary, Buehren5 and Read4 argue that changes in corneal topography is a result of excyclotorsional eye movement during accommodation. When this excyclotorsional eye movement was accounted for in their data analysis, no significant change in corneal topography was found with accommodation. The effect of ciliary relaxation on the cornea curvature, however, was less well delineated.

In this study, we employed Visante-OCT (Carl ZeiIn this study, we employed Visante-OCT (Carl Zeiss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.

ss, USA), an anterior chamber optical coherence tomography, to monitor the change of anterior chamber dimensions. These data were correlated to anterior and posterior curvature changes collected with the Oculus Pentacam (Oculus Inc., Germany), a corneal topographer based on rotating Scheimpflug principle. To minimize the effect of convergence and excyclotorsion during examination, topical cycloplegic medication was used. We hypothesized that if there is a link between ciliary muscle contraction and cornea curvature, installation of cycloplegic should result in widening of anterior chamber angle to angle distance and flattening of the cornea curvature data.

In addition, we would also compare the accuracy in pupil diameter measurements between Pentacam and Visante OCT under under normal and mydratic conditions.

Conditions
Myopia, Astigmatism
Keywords
CORNEAL TOPOGRAPHY, KERATOPLASTY
Medical subject headings
Myopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00838734
Study groupRoleWhat they receive
1Pre-LASIK
2Post-LASIK

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2009 (estimated)
  2. Study startJun 2008
  3. Study completionJun 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00838734
Sponsor's protocol ID
FEMH97011
Status last verified
Feb 2009
First submitted
4 Feb 2009
Last updated
6 Feb 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia and Astigmatism, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2009. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shu-Wen Chang, MD (866-2-8966-7000 ext. 4271, swchang@mail.femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 6 Feb 2009.

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