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Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes

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ClinicalTrials.gov Identifier: NCT00712231
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : July 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
There have been numerous studies comparing various ACD measurements in phakic eyes,while researches comparing ACD in pseudophakic eyes are less extensive. With the recent popularity of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic accommodation from pseudoaccommodation. It is thus mandatory to verify the accuracy of ACD measurement of these devices since the innovation of various IOLs in the recent decade makes this task more complicated. In this study, we will assess the limitations of using Pentacam for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and A-scan measurements.

Condition or disease
Cataract

Detailed Description:
In this prospective study, ACD was measured in 90 phakic and 94 pseudophakic eyes by Pentacam, IOLMaster and A-scan. Correlations and differences between the three measurements were investigated. The accuracy in detecting the anterior lens surface in pseudophakic eyes was also assessed.Differences in ACD-Pen, ACD-IOLM, and ACD-A were analyzed using one-way analysis of variance (ANOVA). When an overall significance of P< 0.05 was obtained, pair-wise comparisons were made using Tukey's multiple comparison t tests. The association between ACD-Pen, ACD-IOLM, and ACD-A was assessed using Pearson's correlation test. The distribution of erroneous ACD-Pen measurement for the three IOLs was analyzed with the chi-square test. In all analyses, P <0.05 was considered statistically significant.

Study Design

Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Assess the Degree of Agreement of Anterior Chamber Depth Measurements by 2 Optical Devices (Pentacam and IOLMaster) and Compare Them With Contact Ultrasound A-Scan in Phakic and Pseudophakic Eyes.
Study Start Date : January 2008
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
phakic eyes
the cases did not accept any intraocular surgery
pseudophakic eyes
tht cases did not accept any intraocular surgery expect for cataract surgery


Outcome Measures

Biospecimen Retention:   None Retained
no specimen

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ninety phakic eyes were randomly selected for study from the outpatient clinic. Ninety-four pseudophakic eyes that had a standard clear cornea phacoemulsification with one of three acrylic IOLs (MA60BM, SA60AT, SN60AT) implanted into the capsular bag by the same surgeon were also studied.
Criteria

Inclusion Criteria:

  • Phakic group: randomized
  • Pseudophakic eyes : the cases accepted cataract surgery

Exclusion Criteria:

  • Previous ocular trauma or intraocular surgery other than cataract surgery;
  • Contact lens use in the past two months;
  • Use of medication that might affect the pupil; corneal disease or ocular infection;
  • History of ocular disease, such as

    • Dry eye syndrome
    • Uveitis
    • Glaucoma
    • Ocular tumor
  • Cases with any surgical complications were also excluded.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712231


Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Shu-Wen Chang Far Eastern Memorial Hospital
More Information

Responsible Party: Shu-Wen Chang/Far Eastern Memorial Hospital, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00712231     History of Changes
Other Study ID Numbers: FEMH97007
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

Keywords provided by Far Eastern Memorial Hospital:
pseudophakic
anterior chamber depth
Pentacam

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases