Research of scleral fixation technique of four-haptic intraocular lens using suture

Phase 1

• Conditions: Aphakia; H27.0

• Registration Number: RBR-6qvmjs
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verify the safety of scleral fixation using Akreos AO60 IOL and Gore-Tex suture, associated with pars plana vitrectomy when necessary.<br>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.

Secondary Outcome Measures

Name	Time	Method
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.