Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
Conditions
Brief summary
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs
Interventions
PROCEDUREMicrocoaxial Phacoemulsification
Sponsors
Iladevi Cataract and IOL Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age related, uncomplicated senile cataracts
Exclusion criteria
* presence of glaucoma, * shallow anterior chamber (ACD \< 2.1mm), * pupillary dilatation \< 6mm, * extremely dense cataracts, * posterior polar cataract, * subluxated cataract, * white mature cataract, * diabetic retinopathy, * high myopia (defined as AL \> 25mm), * uveitis, or * previous ocular trauma/surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal clarity on postoperative day 1 | postoperative day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Central corneal thickness on postoperative day 1 and week 1 | day 1 and week 1 |
Countries
India
Outcome results
None listed