NCT02423668

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

April 19, 2015

Last Update Submit

April 21, 2015

Conditions

Cataract

Keywords

cataract surgerybiometrysecond eye refinementeffective lens position

Outcome Measures

Primary Outcomes (1)

  • Second eye mean absolute error

    Mean of the absolute value of the prediction error of the second eye

    4-6 weeks after second eye surgery

Study Arms (3)

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).

Procedure: 50% Partial adjustment

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).

Procedure: No adjustment

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).

Procedure: Full adjustment

Interventions

50% Partial adjustmentPROCEDURE

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

50% Partial adjustment
No adjustmentPROCEDURE

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

No adjustment
Full adjustmentPROCEDURE

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

Full adjustment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients admitted for bilateral age-related cataract surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Pedro Gil, MSc, MD

    Centro Hospitalar Baixo Vouga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, MD

Study Record Dates

First Submitted

April 19, 2015

First Posted

April 22, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04