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Patient satisfaction and quality of vision following implantation of latest technology based Intraocular Lens implantation after cataract surgery in both eyes

Clinical outcomes and quality of vision following bilateral implantation of a new Extended Depth of Focus (EDoF) Intraocular Lens - EDoF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027105
Enrollment
30
Registered
2020-08-13
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: H251- Age-related nuclear cataract

Interventions

Intervention1: Implantation of new Extended Depth of Focus intraocular lens after cataract surgery: The Zeiss AT LARA 829mp IOL will be implanted i patients after an uneventful cataract surgery. Its o

Sponsors

Dr Sri Ganesh
Lead Sponsor
Carl Zeiss Meditech
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: A patient with cataract for which phacoemulsification or femtolaser assisted cataract surgery with posterior chamber IOL implantation · Male or female in good general health, 40-80 years of age at the time of the pre-operative examination · A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation · A patient with preoperative corneal astigmatism less than 1D and stable corneal conditions within the last 12 months · A patient with clear ocular media other than cataract in each eye · A patient with normal OCT of the macula in each eye

Exclusion criteria

Exclusion criteria: 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 A patient with amblyopia or strabismus A patient with capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye A patient has a history of significant ocular trauma or prior ocular surgery in either eye A patient with cornea guttata, corneal scarring, keratoplasty, irregular astigmatism (e.g. Keratoconus) 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 Need for a dioptre out of the range of +16.0D to +26.0D 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 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

MeasureTime frame
Bilateral,unilateral uncorrected distance visual acuity and Distance corrected visual acuity with ETDRS chart at 4 m Bilateral uncorrected and distance corrected intermediate visual acuity and reading speeds at 60 and 80 cm with Salzburg Reading Desk(SRD) Bilateral uncorrected and distance corrected near vision with ETDRS chart and SRD at 40 cm Defocus curves from +2 to -3 D Contrast sensitivity with CSV 1000 chart. Subjective Questionnare for dysphotopsia and spectacle independenceTimepoint: 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR

Secondary

MeasureTime frame
Spectacle independence for distance, intermediate and near visionTimepoint: 1 WEEK, 1 MONTH, 3 MONTHS, 6 MONTHS AND 1 YEAR

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