Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: MAGNIFICENT IOL: Magnificent IOL is a High-Performance Single piece Extended Depth-of-Focus IOL
manufactured by Synchronized Cast Molding procedure which ensures smooth insertion
and p
Sponsors
CARE GROUP INDIA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 21 years or older at the time of the preoperative visit 2.Visually significant cataract in one / both eyes and willingness to have them surgically removed 3.Clear intraocular media other than cataract in both eyes (vitreous, anterior chamber) 4.Monocular Best Corrected Distance Visual Acuity (BCDVA) in the operative eye between 20/40 and 20/200 5.Corneal astigmatism less than or equal to 0.75 D in the operative eye 6.Regular corneal topography and corneal astigmatism 7.Spontaneously expressing the desire for spectacle independence after surgery and with realistic expectation 8.Potential for postoperative corrected distance visual acuity 20/25 (logMAR 0.10) or better in the operative eye 9.IOL power to reach emmetropia from 16.0 D to 26.0 D, inclusive, for the operative eye 10.Willingness to provide signed written consent prior to participation in any study related procedures 11.Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
Exclusion criteria
Exclusion criteria: PRE-OPERATIVE- 1.Age of patient less than 21 years 2.Active Ocular disease in the operative eye for example chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency 3.Subject with any systemic disease that could increase operative risk or pull found the outcome 4.Pregnant or lactating or planning a pregnancy at the time of enrolment 5.Significant irregular corneal astigmatism 6.Any ocular Co morbidity, amblyopia, axial length more than 25.0 mm 7.Pupil abnormality (non-reactive Tonic pupil, abnormally shaped pupil or pupil that do not dilate under mesopic or scotopic condition) patient on chloroquine treatment 8.Degenerative ocular disorder (macular degeneration, optic nerve atrophy, retinal disorder, corneal guttata, post keratoplasty, corneal scarring, aniridia, amblyopia, previous intraocular surgery (corneal glaucoma or vitreo-retinal surgery) pseudoexfoliation syndrome, intra ocular tumour 9.Any patient who is taking part in another study involving ocular surgery 10.Subject is an employee or immediate family member of Sponsor or investigator?s study staff INTRA-OPERATIVE- 1.Complications occurring during cataract extraction surgery (e.g., torn anterior capsule; posterior capsular rupture, corneal injury such as significant detachment of Descemet?s membrane or significant corneal endothelial damage, inability to adequately remove the crystalline lens material, 2.Vitreous loss or prolapse 3.Zonular weakness, dehiscence or rupture 4.Any capsular bag pathology, fibrosis, or opacification that could not be visualized prior to removing the cataract 5.Any method of anterior capsulotomy other than specified in the protocol (Continuous Curvilinear Capsulorhexis) 6.Significant anterior chamber bleeding 7.Wound burn 8.Pupil diameter less than 6 mm post mydriatic injection 9.Capsulorhexis less than 5 mm and more than 6.5 mm in diameter will be excluded 10.Iris incarceration or damage, excessive iris mobility, or need for iris manipulation prior to or at the time of implantation 11.Mechanical or surgical manipulation required to enlarge pupil prior to or at the time of IOL implantation 12.Any complication that may affect the postoperative lens centration or tilt or that may require additional interventional procedures for correction 13.Lens Element damage 14.Inability to fixate the IOL in the desired position
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Uncorrected distance visual acuity (UDVA) with ETDRS chart 2.Corrected distance visual acuity (CDVA) with ETDRS chart 3.Distance corrected intermediate visual acuity (DCIVA) with ETDRS chart 4.Uncorrected intermediate visual acuity (UIVA) with ETDRS chart 5.Distance corrected near visual acuity (DCNVA) with ETDRS chart 6.Contrast sensitivity 7.Photic phenomena by dysphotopsia questionnaireTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of Vision Index (QVI) 2.Spherical equivalent 3.Defocus curve 4.Subjective refraction 5.Visual disturbance 6.Patient satisfaction 7.Spectacle independence (NEI_VFQ25 questionnaire) at 6 months 8.Reading speed 9.Manifest refractionTimepoint: 6 months;1.Quality of Vision Index (QVI) 2.Spherical equivalent 3.Defocus curve 4.Subjective refraction 5.Visual disturbance 6.Patient satisfaction 7.Spectacle independence (NEI_VFQ25 questionnaire) at 6 months 8.Reading speed 9.Manifest refractionTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
ProClin Research Pvt Ltd
Outcome results
None listed