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Comparison of vision following intraocular lens implantation using two different machines.

Comparison of postoperative outcomes following Toric IOL implantation using an image guided versus a femto laser enabled capsular marking system for intraoperative IOL positioning.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048676
Enrollment
60
Registered
2023-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL IMPLANTATION DONE USING FEMTOLASER ENABLED CAPSULAR MARKING SYSTEM (INTELLIAXIS): PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL

Sponsors

LENSAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: â?? Healthy eyes besides age related cataract, aged between 40-80 years â?? Eyes undergoing femtolaser assisted surgery with implantation of a hydrophobic monofocal toric IOL â?? Regular corneal topography and corneal astigmatism within the range of 0.75D to 4.00D â?? Availability, willingness, and sufficient cognitive awareness to comply with examination procedures â?? Signed informed consent

Exclusion criteria

Exclusion criteria: â?? 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. â?? Subjects with any systemic disease that could increase operative risk or confound the outcome â?? Pregnant or lactating or planning a pregnancy at the time of enrolment â?? Any patient who is taking part in another study involving ocular surgery â?? Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions) â?? Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia

Design outcomes

Primary

MeasureTime frame
â?? Post-op residual cylinder (D) â?? Manifest refraction (Sphere, Cylinder, Spherical Equivalent) â?? Uncorrected Distance Visual Acuity (UDVA) and Corrected Distance Visual Acuity (CDVA) using ETDRS charts at 4m â?? Rotational stability using dilated clinical examination and I-trace (Tracey technologies, Hoya, Japan). Timepoint: 1 WEEK, 1 MONTH, 3 MONTHS

Secondary

MeasureTime frame
1.Precision (Success/ Failure) of intra-operative image capture 2.Intra-operative adverse events /post-op rotation/ re-surgery rateTimepoint: Intraoperative

Countries

India

Contacts

Public ContactDR SHUBHANGI SHEVALE

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026