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Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes
This study has been completed.
Sponsored by: Far Eastern Memorial Hospital
Information provided by: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00712231
  Purpose

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
Cataract

MedlinePlus related topics: Cataract Nuclear Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, 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.

Further study details as provided by Far Eastern Memorial Hospital:

Biospecimen Retention:   None Retained

Biospecimen Description:

no specimen


Enrollment: 184
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
phakic eyes
the cases did not accept any intraocular surgery
pseudophakic eyes
tht cases did not accept any intraocular surgery expect for cataract surgery

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712231

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

Responsible Party: Far Eastern Memorial Hospital ( Shu-Wen Chang/Far Eastern Memorial Hospital )
Study ID Numbers: FEMH97007
Study First Received: July 7, 2008
Last Updated: July 8, 2008
ClinicalTrials.gov Identifier: NCT00712231  
Health Authority: Taiwan: Institutional Review Board

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

Study placed in the following topic categories:
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009