Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03861351
Eligibility Criteria:
Inclusion Criteria:
* Eighteen years of age or older at the time of surgery and diagnosed with bilateral cataracts;
* Planned bilateral cataract removal by phacoemulsification;
* Preoperative total corneal astigmatism of 0.89 - 2.91 D, measured by corneal topography in both operative eyes;
* IOL power and cylinder requirement calculated by the specific web-based Mini Toric Calculator within the following range:
* Cylinder of: 1.50 D to 4.00 D
* Spherical Equivalent of: 18.00 to 28.00 D
* Willing and able to complete all required postoperative visits;
* Clear intraocular media other than cataract;
* Available for second-eye surgery within 2 weeks of the initial operation;
* Potential postoperative visual acuity of 0.3 logMAR in both eyes;
* Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.
Exclusion Criteria:
* Irregular / asymmetric astigmatism;
* Significant irregular corneal aberration as demonstrated by corneal topography;
* Keratopathy / Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomicosis and corneal plana;
* Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjuntivitis and keratouveitis;
* Subjects with diagnosed degenerative visual disorder (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.3 logMAR;
* Subjects who may have reasonably been expected to require a secondary surgical intervention at any time during the study (other than Nd:YAG capsulotomy);
* Subjects in whom the intraocular lens might interfere with the ability to observe, diagnose or treat posterior segment conditions;
* Previous corneal refractive surgery;
* Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens, including but not limited to the following: pseudo-exfoliation syndrome, chronic uveitis, Marfan's Syndrome;
* Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag;
* Absence of adequate support for the lens from the posterior chamber or the zonule;
* Pupil abnormalities, including but not limited to the following: non-reactive, tonic pupils that do not dilatate under mesopic/scotopic conditions, abnormally shaped pupils or abnormally positioned pupils;
* Amblyopia;
* Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy);
* Proliferative diabetic retinopathy;
* Microphthalmos;
* Suspected microbial infection;
* Previous retinal detachment;
* Previous corneal transplant;
* Optic nerve atrophy;
* Extremely shallow anterior chamber, not due to swollen cataract;
* Recurrent severe anterior or posterior segment inflammation of unknown aetiology (e.g. chronic uveitis);
* Iris neovascularization;
* Glaucoma (uncontrolled or controlled with medication);
* Aniridia or iris atrophy;
* Severe dry eye;
* Use of any systemic or topical drug known to interfere with visual performance;
* Subjects with any systemic disease that could increase operative risk or confound the outcomes (e.g. uncontrolled diabetes);
* Use of contact lens within the last 30 days before the preoperative visit;
* Vulnerable subjects (children \<18 years, people in guardianship or trusteeship or inability to give an informed consent);
* Pregnant or lactating or planning a pregnancy at the time of enrolment;
* Subjects with psychiatric disorders that could confound the outcomes;
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
Intra-operative exclusion criteria:
* Irregularity and decentration of capsulorhexis;
* Other ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
* Significant vitreous loss;
* Significant anterior chamber hyphema;
* Uncontrollable intraocular pressure (IOP);
* Zonular or capsular rupture;
* Ciliary sulcus, Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03861351
Study Brief:
Protocol Section:
NCT03861351