A Prospective, randomized, controlled, post-marketing clinical study to assess clinical performance and safety of EYECRYL Sert intraocular lens (IOL) versus TECNIS EyhanceTM IOL in patients with planned age-related cataract surgery
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 134
- Locations
- 3
- Primary Endpoint
- To demonstrate that EYECRYL Sert exhibits non inferiority for Distance
Study Overview
Brief Summary
Presbyopia is one of the most common causes of vision impairment, affecting an estimated 2 billion people, globally . Presbyopia has been associated with negative impacts on quality of life in people aged 40 and above from developing and developed nations alike – because it causes difficulties with reading and with accomplishing near vision tasks.
Non-invasive methods of correcting presbyopia have been used for many years. While bifocal or multifocal progressive addition lenses, monofocal or bifocal contact lenses can provide satisfactory distance and near vision to presbyopes without the potential risks of a surgical procedure, they cannot restore or substitute the true process of accommodation of a younger individual.
Among the surgical options, presbyopia correction can be achieved with excimer or femtosecond laser ablation on cornea (LASIK, PRK, Presbylasik, Supracor, Intracor, etc.), Another recent corneal approach is the insertion of inlays, both artificial and made of corneal tissue in order to change the central curvature of the cornea.
Lens extraction with implantation of multifocal, monofocal (monovision) or accommodative intraocular lenses is another method for correction of presbyopia and has started to become the preferred method for presbyopic correction, particularly in a cataract-aged population. Multifocal IOLs provides good distance and near vision but usually provide not sufficient intermediate vision . Moreover, they might be linked to visually significant light-related experiences that could be highly uncomfortable and necessitate extremely careful patient selection. Therefore, monofocal IOLs continue to be the most commonly used intraocular lenses in cataract surgery. However, there exists a need for an IOL that can provide a favorable compromise between clear distance and intermediate vision, while also addressing issues related to light sensitivity.
The introduction of the newest IOLs with extended depth of focus (EDOF) technology facilitated a relatively favorable visual performance across intermediate, far, and near distances.
This study seeks to compare a new Advanced Monofocal IOL with extended depth of focus vision, the EYECRYL Sert intraocular lens with the TECNIS EyhanceTM IOL.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients having cataract; 2.Female participants of childbearing potential and male participantswhose partner is of childbearing potential must be willing to ensure thatthey or their partner use effective contraception during the study.
Exclusion Criteria
- •1.Systemic disease that could increase the operative risk or confound the outcome 2.Instability of keratometry or biometry measurements and 3.irregular astigmatism.
Outcomes
Primary Outcomes
To demonstrate that EYECRYL Sert exhibits non inferiority for Distance
Time Frame: 1-2days, | 7-14 days, | 30-60 days, | 120-180 days | 330-420 day
Corrected Intermediate Visual Acuity (DCIVA) over TECNIS EyhanceTM
Time Frame: 1-2days, | 7-14 days, | 30-60 days, | 120-180 days | 330-420 day
Secondary Outcomes
- To demonstrate that EYECRYL Sert has at least 50% eyes achieving photopic(monocular DCIVA 0.2 logMAR or better @ 66cm)
Investigators
Dr Krishnaprasad Kudlu
Prasad Netralaya Super Speciality Eye Hospital