Cataract Clinical Trial
— ETDRSOfficial title:
Visual Performance of Pseudophakic Patient With Different Intraocular Lenses
Verified date | February 2016 |
Source | Hospital Oftalmologico de Brasilia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Observational |
This retrospective study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. In all cases, a multifocal and monofocal Intraocular Lens was been implanted in the capsular bag. Three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity was evaluated. A patient-satisfaction and visual phenomena questionnaire was also been administered.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | December 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: Cataract Any race Either gender Diagnosis of cataracts both eyes Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer Subjects must have > 1.00 diopter of astigmatism Exclusion Criteria: Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia Retinal abnormalities Diabetes mellitus steroid or immunosuppressive treatment Connective tissue diseases |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Oftalmologico de Brasilia | University of Sao Paulo |
Brazil,
Alfonso JF, Fernández-Vega L, Ortí S, Ferrer-Blasco T, Montés-Micó R. Refractive and visual results after implantation of the AcrySof ReSTOR IOL in high and low hyperopic eyes. Eur J Ophthalmol. 2009 Sep-Oct;19(5):748-53. — View Citation
Hida WT, Motta AF, Kara-José Júnior N, Costa H, Tokunaga C, Cordeiro LN, Gemperli D, Nakano CT. [Comparison between OPD-Scan results and visual outcomes of Tecnis ZM900 and Restor SN60D3 diffractive multifocal intraocular lenses]. Arq Bras Oftalmol. 2008 — View Citation
Kohnen T, Nuijts R, Levy P, Haefliger E, Alfonso JF. Visual function after bilateral implantation of apodized diffractive aspheric multifocal intraocular lenses with a +3.0 D addition. J Cataract Refract Surg. 2009 Dec;35(12):2062-9. doi: 10.1016/j.jcrs.2009.08.013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Performance in Pseudophakic Patients With Different Intraocular Lens | Postoperative evaluation was been performed at 6 months. The uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) was assessed using the 100% contrast ETDRS chart; a binocular defocus curve was constructed using the ETDRS chart at 4 m. | 6 months postoperative | Yes |
Secondary | Contrast sensitivity | Contrast sensitivity was measured using the CSV-1000 HGT instrument (VectorVision, Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd). The background illumination of the translucent chart does not depend on room lighting. All measurements was obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. The examinations was performed unilaterally at a distance of 2.5 m with BCVA and an undilated pupil. All measurements was performed under the same conditions. | 6 months | No |
Secondary | Patient satisfaction | Patient satisfaction and quality of life was assessed by a simple questionnaire. Patients was interviewed 6 months postoperative. Patients was asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure. | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04685538 -
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
|
Phase 3 | |
Recruiting |
NCT06060041 -
IC-8 Apthera IOL New Enrollment Post Approval Study
|
||
Recruiting |
NCT05518539 -
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
|
||
Recruiting |
NCT05271942 -
Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
|
N/A | |
Active, not recruiting |
NCT04778501 -
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia
|
N/A | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT03751033 -
Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
|
N/A | |
Completed |
NCT02529488 -
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
|
N/A | |
Completed |
NCT04539548 -
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
|
Phase 3 | |
Completed |
NCT03740659 -
Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
|
Phase 2 | |
Completed |
NCT03494257 -
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|
N/A | |
Completed |
NCT05119127 -
Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.
|
N/A | |
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT03739528 -
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
|
Phase 3 | |
Completed |
NCT02888210 -
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
|
Phase 3 | |
Completed |
NCT03356847 -
Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery
|
N/A | |
Completed |
NCT04332640 -
Clinical Evaluation of the Next Generation Phaco System
|
N/A | |
Recruiting |
NCT03638726 -
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
|
Phase 4 | |
Completed |
NCT03050697 -
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
|
N/A |