Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: INTRA-OPERATIVE TORIC IOL IN SMALL PUPILS: 1) To find out the safety, efficacy of usage of intra-operative toric IOL marker.
2)To find out Rotational stability and complications relate
Sponsors
NETHRADHAMA SUPER SPECIALTY EYE HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UCVA, BCVA, ROTATIONAL STABILITY BY ITRACETimepoint: Pre Op visit, Post OP day 1 , day 7 , day 15, day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| UCVA, BCVA, ROTATIONAL STABILITY BY ITRACETimepoint: Pre Op visit, Post OP day 1 , day 7 , day 15, day 60 | — |
Countries
India
Contacts
Public ContactDR SRI GANESH
NETHRADHAMA SUPER SPECIALITY EYE HOSPITAL
Outcome results
None listed