Senile cataract
Conditions
Interventions
A group of 80 patients with cataract will undergo cataract surgery with intraocular lens implantation to correct corneal astigmatism. Patients will be monitored for a period of 6 months, with periodic
Sponsors
Hospital da clínicas da faculdade de medicina de Ribeirão Preto da universidade de São Paulo
Alcon Laboratórios do Brasil
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers over 18 years old; both genders; cataract presence with formal indication for cataract surgery and corneal astigmatism greater than or equal to 1.0 diopter;.
Exclusion criteria
Exclusion criteria: Any eye disease other than cataracts and astigmatism; surgery or previous inflammation; preoperative refraction with spherical equivalent (refractive error) greater than +5.0 diopters or less than -5.0 diopters; irregular astigmatism; optic nerve or macular abnormalities detected with optical coherence tomography.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the magnitude of intraocular lens rotation (in degrees) 6 months after implantation, through photographic records of the patient's eye and comparing it with the preoperative planning. It is expected to determine, with 80% probability, that the magnitude of postoperative lens rotation has an average of less than or equal to 1.5 degrees, which is clinically reasonable to be considered small, or within an acceptable limit for good lens operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the postoperative deviation between predicted and observed refractive astigmatism at 6 months, by measuring the patient's refraction ("spectacle examination"). There is no specified hypothesis associated with secondary outcomes. ;Evaluate the percentage of eyes with intraocular lens rotation greater than 5 and greater than 10 degrees 1 and 6 months after surgery, through photographic records of the patient's eye and comparing it with preoperative planning. There is no specified hypothesis associated with secondary outcomes. ;To evaluate the correlation coefficients between astigmatism (predicted and observed) and centralization, axial displacement (anterior-posterior axis) and intraocular lens rotation 6 months after surgery. The evaluation will be carried out through photographic records of the patient's eye and comparing it with preoperative planning, refraction examination ("spectacle examination"), measurement of vision and examination with an aberrometer (OPD-Scan III). There is no specified hypothesis associated with secondary outcomes. ;Evaluate the postoperative deviation between the spherical equivalent (refractive error) of the predicted and observed refraction in 6 months, through the patient's refraction exam ("spectacles examination"). There is no specified hypothesis associated with secondary outcomes. ;Assess the likelihood of requiring a return to the operating room to reposition a rotated intraocular lens; such assessment will be performed through photographic records of the patient's eye and comparing it with preoperative planning, refraction examination ("spectacles examination"), vision measurement and examination with an aberrometer (OPD-Scan III). There is no specified hypothesis associated with secondary outcomes. | — |
Countries
Brazil
Contacts
Public ContactHeitor Duarte
Outcome results
None listed