Clinical trial NCT00712231: Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: pseudophakic
anterior chamber depth
Pentacam
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 184
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Shu-Wen Chang
role: PRINCIPAL_INVESTIGATOR
References: