Spherical Aberration and Contrast Sensitivity in IOLs

NCT00576485 | Completed Phase 4 DMC

• 2 other identifiers: 490/06ETIC490/06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery. Design: Prospective, comparative, interventional case series. Methods: In an intraindividual randomized prospective study of 25 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of vision was measured by visual acuity and contrast sensitivity under mesopic and photopic conditions. All patients were followed for 3 months.

Conditions

Cataract; Signs and Symptoms; Pseudophakia; Lens Diseases

Keywords

Cataract; Intraocular lens; Spherical aberration; Contrast sensitivity

Outcome Measures

Primary Outcomes (1)

• To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery

  within the first 30 days of surgery

Study Arms (2)

1

EXPERIMENTAL

Cataract surgery and implantation of a spherical intraocular lens

Procedure: Cataract surgery and intraocular lens implantation

2

EXPERIMENTAL

Cataract surgery and implantation of a spherical intraocular lens

Procedure: Cataract surgery and intraocular lens implantation

Interventions

Cataract surgery and intraocular lens implantation PROCEDURE

Cataract surgery and implantation of an intraocular lens

1; 2

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-related cataract
• No indication of existing ocular pathology
• Unsatisfactory correction with glasses and
• Less than 2.50 diopters (D) of topography cylinder.

You may not qualify if:

• Previous ocular surgery
• Central endothelial cell count less than 1800 cells/mm2
• Glaucoma or intraocular pressure greater than 21 mmHg
• Amblyopic eyes
• Retinal abnormalities
• Diabetes mellitus
• Steroid or immunosuppressive treatment, and
• Connective tissue diseases

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais - Sao Geraldo Eye Hospital

Belo Horizonte, Minas Gerais, 31270000, Brazil

Location

Related Publications (1)

• Tzelikis PF, Akaishi L, Trindade FC, Boteon JE. Spherical aberration and contrast sensitivity in eyes implanted with aspheric and spherical intraocular lenses: a comparative study. Am J Ophthalmol. 2008 May;145(5):827-33. doi: 10.1016/j.ajo.2007.12.023. Epub 2008 Mar 4.

  PMID: 18291345 DERIVED

MeSH Terms

Conditions

Cataract; Signs and Symptoms; Pseudophakia; Lens Diseases

Interventions

Cataract Extraction; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Eye Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Patrick F Tzelikis, MD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: February 1, 2005
• Study Completion: December 1, 2007
• Last Updated: October 20, 2008

Record last verified: 2007-12

Locations

BR (1)