A Clinical trial to study the effect and Safety of Novel suture device S-FIX in patients undergoing Scleral fixated IOL surgery
Not Applicable
- Conditions
- Health Condition 1: H598- Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified
- Registration Number
- CTRI/2023/06/053566
- Lead Sponsor
- Aurolab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a) All patients with aphakia who require SFIOL implantation
b) Both post cataract surgery and post trauma aphakia are included
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method percentage of patients showing 1-2 lines of improvement in BCVA chi square testTimepoint: 45 days
- Secondary Outcome Measures
Name Time Method -Intraoperative and post-operative complications-Percentage (Categorical) <br/ ><br>-IOL tilt assessment-percentage of eyes with tilt and mean IOL tilt in degree, continuous variable <br/ ><br>-Difference between pre-operative and POD 45 corneal endothelial cell count (wilcoxan signed rank test) <br/ ><br>Difference between mean pre-operative CMT and CMT at POD 45 (wilcoxan signed rank test)Timepoint: 45 days