A prospective, single centre, observational study on the visual performance of an enhanced monofocal IOL post phaco-emulsification cataract surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (Eyhance IOL - Johnson and Johnson vision) with emmetropia as a target refraction.
Study Overview
Brief Summary
This prospective observational study evaluates the real-world visual performance of enhanced monofocal intraocular lenses (IOLs), specifically the Johnson & Johnson Vision Eyhance lens, implanted bilaterally after uncomplicated phacoemulsification. Beyond standard visual acuity testing for distance, intermediate, and near vision, the study assesses advanced parameters such as pupillometry (under mesopic and photopic conditions), contrast sensitivity, and defocus curves under uniocular and binocular settings. Patient-reported outcomes will be captured using the validated Catquest-9SF questionnaire. The goal is to provide a comprehensive understanding of visual quality and functionality with enhanced monofocal IOLs to inform better patient selection and counseling in cataract surgery.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Undergone bilateral implantation with Johnson and Johnson Tecnis Eyhance enhanced monofocal IOL.
- •Willingness to undergo minimum follow up period of 1 month after second eye cataract surgery.
- •Pre Op corneal astigmatism less than/equal to 0.75D.
Exclusion Criteria
- •Age 20-80 Years except cataract History of trauma or previous ocular surgery.
- •Axial length over 25mm Pre-existing corneal pathology.
- •Glaucoma or optic neuropathy.
- •Diabetic retinopathy or macular degeneration.
- •• Systemic conditions affecting neuro-ocular pathways.
- •• Intra-operative complications (e.g. posterior capsular rupture, IOL outside the bag).
Outcomes
Primary Outcomes
To evaluate visual and refractive outcomes, as well as patient satisfaction after bilateral implantation of an enhanced monofocal intraocular lens (Eyhance IOL - Johnson and Johnson vision) with emmetropia as a target refraction.
Time Frame: Day1, Day7, Day15, 1 Month.
Secondary Outcomes
- To compare visual outcomes with preoperative parameters and with established data from conventional monofocal IOLs.(To assess the extent of spectacle independence achieved by the patients for various visual functions and activities of daily living using Catquest-9SF questionnaire.)
Investigators
Shubham Vivek Naik
Bhaktivedanta Hospital and research institute