Assessment of Toric IOL Rotational stability between three Toric IOLs
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 1. To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).
Study Overview
Brief Summary
MATERIALS AND METHODS:
This prospective, interventional, single centre study will be approved by the institutional ethics committee of Nethradhama Super Speciality Eye Hospital and will adhere to the tenets of declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.
PREOP VISIT
Subjects will provide demographic information and medical history and will undergo the following visits at preoperative visit.
· Visual acuity testing
· Refraction
· Slit lamp examination
· IOP evaluation using NCT
· Dilated fundus examination
· Biometry using IOL Master 700
IOL power is calculated using Barrett TK Toric formula. All the eyes will be targeted for emmetropia.
· Corneal topography – Pentacam (Oculus) – to rule out irregular astigmatism.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Unilateral implant; Eyes with grade 1-4 nuclear sclerosis, cortical cataracts, posterior subcapsular cataract Eyes with regular corneal astigmatism 0.75-5D In the bag IOL implantation.
Exclusion Criteria
- •Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts Post refractive surgery, History of any previous ocular surgery Complicated cataract Glaucoma, posterior segment pathology retinopathy History of uveitis.
Outcomes
Primary Outcomes
1. To analyse and compare the rotational stability of three toric IOL’S- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).
Time Frame: performed for 1 day, 2 weeks, and 3 months after surgery.
Secondary Outcomes
- 2. To assess visual acuity between three toric IOLs’- Eyecryl toric (Biotech), Clareon toric (Alcon) , Eyehance toric (Johnson & Johnson).(performed for 1 day, 2 weeks, and 3 months after surgery.)
Investigators
Dr Sri Ganesh
Nethradhama superspeciality eye hospital