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Completed

NCT Number: NCT02423668

Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

50% Partial adjustment

Procedure

Second eye refinement in the IOL power selection for the second eye using a theoretical 50% partial adjustment of the PE1.

No adjustment

Procedure

IOL power selection for the second eye irrespective of first eye prediction error

Full adjustment

Procedure

Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Baixo Vouga

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2015
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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