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Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens

ConditionPostoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCarl Zeiss Meditec AG

About this trial

This is a prospective, Phase IV, post-approval observational study evaluating postoperative outcomes in patients with a history of myopic corneal laser vision correction (LVC) undergoing bilateral cataract surgery with implantation of the CT LUCIA 621P intraocular lens (IOL). Up to 30 subjects (60 eyes) will be enrolled across up to three U.S. investigational sites. The study will assess visual and refractive outcomes, including biometry, manifest refraction, and patient-reported visual function over a 3-month follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be at least 18 years of age or older.

Previous cornea LVC surgery performed at least 1 year before the implantation of the CT LUCIA 621P IOL, such as Laser-Assisted Intrastromal Keratomileusis (LASIK), Laser-Assisted Subepithelial Keratectomy (LASEK), Photorefractive Keratectomy (PRK) or Small Incision Lenticule Extraction (SMILE) for mild to moderate myopia, with or without astigmatism (up to, but not including, -6.0 D sphere in any meridian for myopic ablations.

Presenting for planned bilateral cataract extraction with in-the-bag posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS). Astigmatism management techniques, such as Astigmatic Keratotomy (AK), may be utilized during cataract surgery to target a predicted postoperative cylinder less than 0.75 D.

Clear intraocular media other than cataract (i.e., no hyphema, vitreous hemorrhage).

Disqualifiers

Implantation of an IOL other than the CT LUCIA 621P in one or both eyes.

Eyes with preoperative anterior corneal astigmatism of ΔTK ≥1.00 D as measured by the IOLMaster 700 or with greater than 0.75 D predicted post-operative astigmatism at the spectacle plane.

Visual field loss which has an impact on visual acuity.

Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would confound visual acuity measurement.

Trial population

This prospective Phase IV post-approval study will enroll up to 30 subjects (60 eyes) at up to three U.S. sites. Eligible adults undergoing bilateral cataract surgery with the CT LUCIA 621P IOL will be enrolled after providing informed consent. Subjects must meet all protocol-defined inclusion and exclusion criteria. Those with complete baseline and Month 3 postoperative biometry and manifest refraction data in both eyes will be considered evaluable. All implanted eyes will be included in safety and efficacy analyses.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CT LUCIA 621P Intraocular Lens Implantation

    Device

    The intervention consists of bilateral implantation of the CT LUCIA 621P intraocular lens (IOL) during routine cataract surgery in patients with a history of myopic corneal laser vision correction. The CT LUCIA 621P IOL is an approved, single-piece, hydrophobic acrylic lens designed to provide improved visual quality and refractive stability. Implantation is performed following each investigator's standard surgical procedures, including preoperative preparation, operative technique, and postoperative care. IOL power calculation uses the ZEISS Cataract Workflow platform with the VERACITY system and Barrett True-K with TK formula, incorporating the VERION Optical Coherence (VOC) technology.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CT LUCIA 621P IOL Implantation Group1 intervention

Trial outcomes

Primary outcomes

1

Mean Prediction Error (PE)

The average difference between postoperative manifest refraction spherical equivalent (MRSE) and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.

Time frame
3 months postoperatively
2

Median Prediction Error (PE)

The median difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.

Time frame
3 months postoperatively
3

Absolute Prediction Error (PE)

The absolute value of the difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.

Time frame
3 months postoperatively
4

Percentage of Eyes Within ±0.25 D of Predicted MRSE

The proportion of eyes achieving postoperative MRSE within ±0.25 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.

Time frame
3 months postoperatively

Secondary outcomes

1

Corrected Distance Visual Acuity (CDVA)

Monocular and binocular postoperative corrected distance visual acuity measured by standard methods.

Time frame
3 months postoperatively
2

Uncorrected Distance Visual Acuity (UDVA)

Monocular and binocular postoperative uncorrected distance visual acuity.

Time frame
3 months postoperatively

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
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