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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712231
• Other study ID #: FEMH97007
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: July 8, 2008
• Start date: January 2008
• Est. completion date: February 2008

Study information

• Verified date: July 2008
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital