Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

Cataract Clinical Trial

— IOL  

Official title:

Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876707
• Other study ID #: 0088/09
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 3, 2009
• Last updated: July 1, 2010
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: April 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria:

• Any ocular diseases, such as:

• corneal opacities or irregularity

• dry eye

• amblyopia

• anisometropia

• glaucoma

• retinal abnormality

• Surgical complications

• IOL tilt

• IOL decentration greater than 0.4 mm (estimated by retroillumination)

• Incomplete follow-up

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• Tecnis implant
Implant of diffractive multifocal IOL Tecnis
• ReSTOR implant
Implant of multifocal IOL ReSTOR
• ReZoom implant
Implant of multifocal IOL ReZoom

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity, wavefront data and modulation transfer function		30, 90 and 120 days after surgery	No
Secondary	contrast sensitivity		90 days after surgery	No