Aphakia
Conditions
Interventions
Fixation of a four-point hydrophilic acrylic intraocular lens (IOL) on the sclera, the Akreos AO60, using Gore-Tex suture in the absence of capsular support associated with pars plana vitrectomy when
Procedure/surgery
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years old; aphakic or subluxated or dislocated IOL; absence of safe capsular support; corrected visual acuity better or equal to 5 letters for uncorrected acuity.
Exclusion criteria
Exclusion criteria: Patients with capsular support that made possible IOL implantation without scleral fixation; ocular comorbidities that could be aggravated by surgery; endothelial cell count less than 1000 cells and/or qualitative changes on specular microscopy as polymegatism and pleomorphism that, in the opinion of the investigator, were high risk for postoperative bulls keratopathy; systemic comorbidity that contraindicated the surgical procedure.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the change in corrected visual acuity during the 6 months of study compared to baseline visit. ;Describe the results which are related to the final outcome of the surgery, such as synechia formation and intraocular lens centralization. | — |
Primary
| Measure | Time frame |
|---|---|
| Verify the safety of scleral fixation using Akreos AO60 IOL and Gore-Tex suture, associated with pars plana vitrectomy when necessary. For this, the following postoperative parameters will be evaluated: change in anterior chamber cells score during the 6 months postoperatively in relation to the basal visit; percentage of patients with conjunctival inflammation; percentage of patients with erosion of the suture through the conjunctiva; percentage of patients with intraocular pressure increase above 5 mmHg in relation to baseline and its variation; percentage of patients with chronic corneal edema (no resolution after 3 months postoperatively); change in endothelial cell density during the 6 months postoperatively from baseline visit; change in the coefficient of variability during the 6 months postoperatively in relation to the basal visit; change in corneal thickness during the 6 months postoperatively from baseline visit; percentage of patients with intraocular lens opacification. | — |
Countries
Brazil
Contacts
Public ContactNatacha Junqueira
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Outcome results
None listed