An observational study to evaluate safety and effectiveness of hydrophilic acrylic intraocular lens.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 352

Inclusion Criteria

Patients of any gender, aged 18 years or older 2.
Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye 3.
Patient is willing and capable of providing informed consent 4.
Patient is willing and capable of complying with visits and procedures as defined by this protocol.

Exclusion Criteria

Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal) 2.
Endothelial cell count of less than 2000/mm2 3.
Ocular disorder that could potentially cause a clinically significant future visual acuity loss 4.
Preoperative corneal astigmatism â‰¥ 1 D or preoperative corneal astigmatism â‰¥ 1.5 D, if postoperative corneal astigmatism is not estimated to be < 1 D.
Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 6.
Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) 7.
Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) 8.
Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis 9.
Any acute infection (acute ocular disease, external/internal infection, systemic infection) 10.
Any previous intraocular and corneal surgery 11.
Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment 12.
Current systemic or ocular pharmacotherapy that effects patientsâ€™ vision 13.
Current pathology or condition that could be a risk for the patient according to the investigator opinion 14.
Women during pregnancy and/or lactation 15.
Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial 16.
Patients whose freedom is impaired by administrative or legal order 17.
Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patientsâ€™ vision Note All eye-related inclusion and exclusion criteria are applicable to the study eye only.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two co-primary effectiveness endpoints assessing the monocular corrected distance visual acuity (CDVA) and the monocular distance-corrected near visual acuity (DCNVA), will be analysed on a binary level (responder analysis). Responders regarding the two endpoints are defined as:	6 Months
Responder regarding DCNVA:	6 Months
Responder regarding CDVA: The achievement of a monocular CDVA of 0.3 LogMAR or better of the study eye, measured at 400 cm, 6 months after the implantation of the AT LISA 809M/MP.	6 Months
The achievement of a monocular DCNVA of 0.3 LogMAR or better of the study eye, measured at 35 cm, 6 months after the implantation of the AT LISA 809M/MP.	6 Months

Secondary Outcome Measures

Name	Time	Method
1.Monocular corrected distance visual acuity (CDVA)	2.Monocular distance-corrected near visual acuity (DCNVA)
Secondary safety End Points	1. IOL status

Trial Locations

Locations (3): Grewal Eye Institute
🇮🇳
Chandigarh, CHANDIGARH, India
Nehtradhama Superspeciality Eye Hospital
🇮🇳
Bangalore, KARNATAKA, India
Prasad Netralaya
🇮🇳
Udupi, KARNATAKA, India
Grewal Eye Institute
🇮🇳Chandigarh, CHANDIGARH, India
Dr Sartaj Singh Grewal
Principal investigator
9779716169
sartajg@gmail.com