Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

Cataract Clinical Trial

Official title:

Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423668
• Other study ID #: CHBaixoVouga3
• Status: Completed
• Phase: N/A
• First received: April 19, 2015
• Last updated: April 21, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Centro Hospitalar do Baixo Vouga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

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
IOL power selection for the second eye irrespective of first eye prediction error
• Full adjustment
Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Baixo Vouga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No