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| Sponsored by: |
Hospital Universitario Ramon y Cajal |
|---|---|
| Information provided by: | Hospital Universitario Ramon y Cajal |
| ClinicalTrials.gov Identifier: | NCT00742950 |
Purpose
The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.
Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.
Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.
| Condition | Intervention |
|---|---|
|
Cataract Refractive Surgery Astigmatism |
Procedure: Nasal 2.8-mm corneal incision Procedure: Temporal 2.8-mm corneal incision Procedure: Superior 2.8-mm incision |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery |
| Estimated Enrollment: | 108 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Active Comparator
Nasal 2.8-mm corneal incision
|
Procedure: Nasal 2.8-mm corneal incision
Phacoemulsification through a nasal 2.8-mm incision
|
|
II: Active Comparator
Temporal 2.8-mm corneal incision
|
Procedure: Temporal 2.8-mm corneal incision
Phacoemulsification through a 2.8-mm temporal incision
|
|
III: Active Comparator
Superior 2.8-mm corneal incision
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Procedure: Superior 2.8-mm incision
Phacoemulsification through a superior 2.8-mm corneal incision
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: María J Prada, MSc | 91-3368000 ext 8915 | mjprada.hrc@salud.madrid.org |
| Spain | |
| Dept Ophthalmology, Hospital Universitario Ramón y Cajal | Recruiting |
| Madrid, Spain, 28034 | |
| Contact: Antonio Mendívil, MD, PhD 913368000 ext 9008 amendivil@ya.com | |
| Principal Investigator: Jaime Tejedor, MD, PhD | |
| Sub-Investigator: José A Pérez-Rodríguez, MD | |
| Principal Investigator: | Jaime Tejedor, MD, PhD | Dept Ophthalmology |
| Study Chair: | José A Pérez-Rodríguez, MD | Dept Ophthalmology |
More Information
| Responsible Party: | Hospital Ramón y Cajal ( Jaime Tejedor / Dr ) |
| Study ID Numbers: | CINPHACO |
| Study First Received: | August 26, 2008 |
| Last Updated: | August 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00742950 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Corneal incision Cataract surgery Phacoemulsification Surgically induced astigmatism Corneal Topography |
|
Eye Diseases Cataract Lens Diseases Refractive Errors Astigmatism |
