Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

April 21, 2015 updated by: Pedro Gil, Centro Hospitalar do Baixo Vouga
To study the effective lens position concept in second eye refinement (SER) cataract surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in Pentacam and SER refractive outcomes.

Study Overview

Detailed Description

A retrospective chart review was conducted, including demographics (age and gender) and several parameters for both the first and second eyes, including the intra-ocular lens power calculation using the HofferQ, SRK/T and Holladay 1 formulas. Pentacam HR was used for pseudophakic anterior chamber depth measurement, and manual measurement was performed by a single investigator tracing a line between the anterior surface of the intra-ocular lens and the central corneal epithelium apex. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the prediction error of the first eye. To relate refractive outcomes to pACD values, the investigators performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).

Study Type

Observational

Enrollment (Actual)

88

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients recruited from the electronic database of a single ophthalmological center as having performed bilateral cataract surgery between 1st June 2013 and 24th July 2014

Description

Inclusion Criteria:

  • patients admitted for bilateral age-related cataract surgery

Exclusion Criteria:

  • Age < 18 years old
  • Previous or combined ocular surgery
  • Manual extracapsular cataract extraction and not phacoemulsification
  • Corneal sutures
  • Implantation of any other IOL type
  • IOL implanted in the sulcus
  • Intra or postoperative complication
  • Post-operative best-corrected visual acuity worse than 5/10
  • Anterior corneal astigmatism>3.00 D
  • Inadequate cooperation for Pentacam HR examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
50% Partial adjustment
The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the PE1. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).
Second eye refinement in the IOL power selection for the second eye using a theoretical 50% partial adjustment of the PE1.
No adjustment
The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. The intra-ocular lens power selection for the second eye was performed irrespective of the first eye prediction error. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).
IOL power selection for the second eye irrespective of first eye prediction error
Full adjustment
The prediction error for the first (PE1) and second (PE2) eyes was calculated as the difference between the observed post-operative refraction in spherical equivalent and the predicted post-operative refraction by the IOL Master for the implanted intra-ocular lens. This was obtained for the 3 formulae. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 100% partial adjustment of the PE1. To relate refractive outcomes to pACD values, we performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).
Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second eye mean absolute error
Time Frame: 4-6 weeks after second eye surgery
Mean of the absolute value of the prediction error of the second eye
4-6 weeks after second eye surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pedro Gil, MSc, MD, Centro Hospitalar Baixo Vouga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 19, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHBaixoVouga3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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