Multi-formula Optimization of Second Eye Refinement According to Direction of the Prediction Error of the First Eye

NCT02270879 | Completed

• 1 other identifier: CHBaixoVouga
• Study Type: observational
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prediction errors for the first (PE1) and second eyes (PE2) were obtained in the intra-ocular lens power calculation for 4 formulae (HofferQ, SRK II, SRK/T and Holladay 1). The optimal correction factor for each formula was determined as the one resulting in the lowest mean absolute error. A similar analysis was performed in the negative and positive PE1 subgroups.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Second eye mean absolute error (mean of the absolute value of the prediction error)

  6 weeks after date of cataract surgery

Secondary Outcomes (1)

• Percentage of second eyes with a post-operative refraction within ±0.50 D and ±1.00 D of the targeted refraction

  6 weeks after date of cataract surgery

Study Arms (1)

Main group

Patients having performed bilateral consecutive cataract surgery between 1st October 2012 and 24th April 2014 in a single ophthalmological center (Centro Hospitalar Baixo Vouga, Portugal).

Procedure: Phacoemulsification cataract surgery

Interventions

Phacoemulsification cataract surgery PROCEDURE

Phacoemulsification of cataract (opacified lens) using clear corneal approach. Implantation of a intra-ocular lens in the capsular bag

Main group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from a single ophthalmological center (Centro Hospitalar Baixo Vouga, Portugal) admitted for bilateral consecutive cataract surgery

You may qualify if:

• Patients having performed bilateral cataract surgery between 1st October 2012 and 24th April 2014 in a single ophthalmological center (Centro Hospitalar Baixo Vouga, Portugal)

You may not qualify if:

• Inadequate follow-up
• Incomplete medical records
• Previous or combined ocular surgery
• Manual extracapsular cataract extraction and not phacoemulsification
• Corneal sutures
• Implantation of any other IOL type different from Abbott Tecnis® 1-piece IOL (Abbott Laboratories Inc., Illinois, USA), ZCB00
• IOL implanted in the sulcus
• Intra or postoperative complication
• Post-operative best corrected visual acuity worse than 5/10
• Corneal astigmatism\>3.00 D

Sponsors & Collaborators

• Centro Hospitalar do Baixo Vouga: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Pedro Gil, MD, MSc

  Centro Hospitalar do Baixo Vouga

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10