CTRI/2026/04/107365Not yet recruitingUnknown
A Prospective single arm clinical study to assess the clinical outcomes and patient satisfaction of a pre-loaded Swiss Phob Toric Hydrophobic intraocular lens in patients undergoing bilateral cataract surgery.
Prof D Lional Raj1 site in 1 country30 target enrollmentStarted: April 21, 2026Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
Study Overview
Brief Summary
The objectives of this study are to evaluate the binocular visual acuity for far, intermediate and near distance, and to measure the Defocus Curve, Contrast Sensitivity & patient satisfaction among patients undergoing binocular cataract with Advanced Monofocal Aspheric intraocular lens implantation.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms;
- •Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation Have corneal thickness more than600 µm by OCT
- •Less than or equal to 1.0 D of preoperative keratometric astigmatism
- •Clear intraocular media other than cataract
- •Given written informed consent by subject.
- •Subjects are willing and able to comply with schedule for follow up visits
- •Subjects should be 22 years or older.
Exclusion Criteria
- •Systemic disease that could increase the operative risk or confound the outcome;
- •Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator [tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)];
- •Ocular condition that may predispose for future complications
- •Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject
- •Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes;
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse
- •If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
Investigators
Dr Lional Raj D
Dr. Agarwals Eye Hospital
Study Sites (1)
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