Health Condition 1: H598- Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified
Conditions
Interventions
Intervention1: S FIX device: The S FIX device used for Intra ocular Haptic fixation in the sclera during Scleral fixated intraocular surgeries
It is made of medical grade Stainless steel surgical nee
Sponsors
Aurolab
Eligibility
Inclusion criteria
Inclusion criteria: a) All patients with aphakia who require SFIOL implantation b) Both post cataract surgery and post trauma aphakia are included
Exclusion criteria
Exclusion criteria: a) History of glaucoma or uveitis b) Any other retinal pathology other than dislocated nucleus or intraocular lens c) Penetrating keratoplasty and any other combined procedures d) Monocular patients e) Pediatric age group less than 18 years of age f) Patients who are not willing to consent for the procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients showing 1-2 lines of improvement in BCVA chi square testTimepoint: 45 days | — |
Secondary
| Measure | Time frame |
|---|---|
| -Intraoperative and post-operative complications-Percentage (Categorical) -IOL tilt assessment-percentage of eyes with tilt and mean IOL tilt in degree, continuous variable -Difference between pre-operative and POD 45 corneal endothelial cell count (wilcoxan signed rank test) Difference between mean pre-operative CMT and CMT at POD 45 (wilcoxan signed rank test)Timepoint: 45 days | — |
Countries
India
Contacts
Public ContactDR Prabhu Baskaran
Aravind Eye Hospital
Outcome results
None listed