Health TrialsbyHealthPanel

Evaluation of a Monofocal Intraocular Lens

ConditionCataract
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorCarl Zeiss Meditec AG

About this trial

The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be at least 50 years of age or older, male or female, of any race or ethnicity.

Presenting for uncomplicated bilateral cataract surgery for age-related cataract.

Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).

Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).

Disqualifiers

Corneal Astigmatism of >1.0 D.

Planned monocular cataract extraction.

Visual field loss which has an impact on visual acuity.

Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.

Trial design

Design model

Single group

Treatments tested in this trial

  • CT LUCIA 621P

    Device

    The device under investigation, CT LUCIA 621P IOL (Carl Zeiss Meditec, Jena, Germany) is a posterior chamber intraocular lens which is indicated for aphakia after surgical extraction of the cataractous natural lens. It is a monofocal aspheric IOL made of hydrophobic material and coated with heparin. The modified C-loop haptic is step-vaulted.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Bilateral implantation of investigational deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Monocular best corrected distance visual acuity (CDVA)

The primary efficacy endpoint is the proportion of patients with monocular CDVA of 20/40 or better at three months

Time frame
Three (3) Months

Secondary outcomes

1

Binocular Corrected Distance Visual Acuity

Time frame
Three (3) Months
2

Monocular Uncorrected Distance Visual Acuity

Time frame
Three (3) Months
3

Monocular Distance Corrected Intermediate Visual Acuity

Time frame
Three (3) Months
4

Monocular Uncorrected Intermediate Visual Acuity

Time frame
Three (3) Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carl Zeiss Meditec AG

Lead sponsor

Source ClinicalTrials.gov
Apply now