Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

NCT ID: NCT02423668

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-03-31

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.

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).

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

50% Partial adjustment

Intervention Type: PROCEDURE

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).

No adjustment

Intervention Type: PROCEDURE

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).

Full adjustment

Intervention Type: PROCEDURE

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

Interventions

50% Partial adjustment

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

Intervention Type: PROCEDURE

No adjustment

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

Intervention Type: PROCEDURE

Full adjustment

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar do Baixo Vouga

OTHER

Sponsor Role: lead

Responsible Party

Pedro Gil

MSc, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro Gil, MSc, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Baixo Vouga

Other Identifiers

CHBaixoVouga3

Identifier Type: -

Identifier Source: org_study_id