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To evaluate clinical outcomes and patient satisfaction with new diffractive Trifocal Intraocular lens

A Prospective single centre post market clinical followup study to investigate the clinical outcomes of a hydrophobic trifocal IOL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021647
Enrollment
30
Registered
2019-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H259- Unspecified age-related cataract

Interventions

Intervention1: Use of new EYECRYL TRI-ACTV TRIFOCAL IOL following bilateral cataract surgery: patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lens

Sponsors

Nethradhama super speciality eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Bilateral Implantation 2 Age of patient >21 Years 3 Cataractous eyes with no comorbidity. 4 Regular corneal topography and corneal astigmatism 5 Preoperative & postoperative corneal astigmatism of 6 Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. 7 Availability, willingness and sufficient cognitive awareness to comply with examination procedures 8 Signed informed consent.

Exclusion criteria

Exclusion criteria: 1 Age of patient 2 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 3 Subjects with any systemic disease that could increase operative risk or confound the outcome 4 Pregnant or lactating or planning a pregnancy at the time of enrolment 5 Any patient who is taking part in another study involving ocular surgery 6 Significant irregular corneal astigmatism. 7 Any ocular comorbidity 8 Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions) Patients receiving chloroquine treatment.

Design outcomes

Primary

MeasureTime frame
1.Uncorrected Distance Visual Acuity (UDVA) with ETDRS charts. 2.Corrected Distance Visual Acuity (CDVA) with ETDRS charts. 3.Distance Corrected Intermediate Visual Acuity (DCIVA) with ETDRS charts. 4.Uncorrected Intermediate Visual Acuity (UIVA) with ETDRS charts. 5.Distance Corrected Near Visual Acuity (DCNVA)with ETDRS charts. 6.Contrast sensitivity using CSV-1000 7. Photic phenomena by Dysphotposia questionnaire 8.Patient Outcome QuestionnaireTimepoint: pre operative visit , post operative visit 1 week , 1,3,6,12 months followup

Secondary

MeasureTime frame
1.Manifest refraction 2.High Order Aberration/Internal and Total Aberration 3.Defocus Curve 4.PCO rate 5.Endothelial Cell Count 6.Reading Speed 7.Objective Scatter Index 8.Fundus Visualization 9.Pupil Size 10.IOL Tilt /decentration/dislocation 11.Adverse EventsTimepoint: pre operative visit , post operative visit 1 week , 1,3,6,12 months followup

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama Super Speciality Eye Hospital

phacomaverick@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026