Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three
Study Details
Study Description
Brief Summary
The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.
Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.
Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Restor +3 patients will be implanted bilaterally with Restor + 3 |
Other: Implantation of a multifocal Intraocular lens
Bilateral implantation of a multifocal IOl
Other Names:
|
| restor +4 Patients will be implanted bilaterally with Restor +4 |
Other: Implantation of a multifocal Intraocular lens
Bilateral implantation of a multifocal IOl
Other Names:
|
Outcome Measures
Primary Outcome Measures
- distance,intermediate and near visual acuity [1, 3 and 6 months]
Secondary Outcome Measures
- reading speed and contrast sensitivity [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)
Exclusion Criteria:
-
Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
-
Surgical complications
-
Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
-
Incomplete follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of São Paulo | São Paulo | SP | Brazil | 054000 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Principal Investigator: Marcony Santhiago, MD, University of São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
- Alfonso JF, Fernández-Vega L, Amhaz H, Montés-Micó R, Valcárcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.
- Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.
- Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.
- Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.
- MRS.1703