CLINICAL ASSESSMENT AND VALIDATION OF A NEW TORIC IOL MARKER FOR INTRA-OPERATIVE ALIGNMENT OF TORIC IOLS IN SMALL PUPILS DURING PHACOEMULSIFICATION - TORIC IOL MARKER

ETHRADHAMA SUPER SPECIALTY EYE HOSPITA0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients having small pupil (Less than 7mm)- PXF/ diabetic patients with mid dilating pupil/Non- dilating pupil with cataract for which phacoemulsification or femtolaser assisted cataract surgery with posterior chamber Toric IOL implantation
•2.Post Femtolaser related miosis with cataract
•3.Patients who fail to dilate on the day of surgery even though Pre-Op assessment showed well dilating pupil
•4.Male or female in good general health, 40-80 years of age at the time of the pre-operative examination
•5.A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
•6.A patient with preoperative corneal astigmatism more than 1D and stable corneal conditions within the last 12 months
•7.A patient with clear ocular media other than cataract in each eye
•8.A patient with normal OCT of the macula in each eye

•1.Patients having fully dilated pupil on table (Femto/ Non- Femto cases)
•2.A patient with a known pathology that may affect visual acuity (as determined by the Investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye
•3.A patient with amblyopia or strabismus
•4.A patient with capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye
•5.A patient has a history of significant ocular trauma or prior ocular surgery in either eye
•6.A patient with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism (e.g. Keratoconus)
•7.A patient that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period in either eye
•8.Need for a dioptre out of the range of +16.0D to +26.0D
•9.A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
•10.A patient currently participating or has participated within 30 days prior to the start of this study in a drug or other investigational research study

发起方

ETHRADHAMA SUPER SPECIALTY EYE HOSPITA