Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

Sponsor

Centro Hospitalar do Baixo Vouga (Other)

Overall Status

Completed

CT.gov ID

NCT02423668

Collaborator

(none)

Enrollment

1.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: 50% Partial adjustment Procedure: No adjustment Procedure: Full adjustment

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 Design

Study Type:

Observational

Actual Enrollment :

88 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	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).	Procedure: 50% Partial adjustment 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).	Procedure: No adjustment 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).	Procedure: Full adjustment Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.

Arm

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).

Procedure: 50% Partial adjustment

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).

Procedure: No adjustment

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).

Procedure: Full adjustment

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

Outcome Measures

Primary Outcome Measures

Second eye mean absolute error [4-6 weeks after second eye surgery]
Mean of the absolute value of the prediction error of the second eye

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro Hospitalar do Baixo Vouga

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pedro Gil, MSc, MD, Centro Hospitalar do Baixo Vouga

ClinicalTrials.gov Identifier:

NCT02423668

Other Study ID Numbers:

CHBaixoVouga3

First Posted:

Apr 22, 2015

Last Update Posted:

Apr 22, 2015

Last Verified:

Apr 1, 2015

Keywords provided by Pedro Gil, MSc, MD, Centro Hospitalar do Baixo Vouga

cataract surgery

biometry

second eye refinement

effective lens position

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Apr 22, 2015