To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity Clinical Trial
| Verified date | March 2009 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Brazil | University of São Paulo | São Paulo | SP |
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | distance,intermediate and near visual acuity | 1, 3 and 6 months | Yes | |
| Secondary | reading speed and contrast sensitivity | 6 months | Yes |