Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision CorrectionNCT07084545
Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
An observational study of Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction, run by Carl Zeiss Meditec AG at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction
- What is being tested?
- CT LUCIA 621P Intraocular Lens Implantation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
- No visual acuity limiting corneal or retinal pathologies.
- Able to and having provided written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.
- Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.
Who cannot join
- 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.
- Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.
- Eyes with irregular corneal astigmatism, epithelial basement membrane dystrophy, chronic dry eye requiring continual treatment, underwent more than one LVC procedure in one or both eyes, or complications from the previous LVC which required additional surgical intervention.
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- Subjects with planned ocular surgery during the study (except Nd:YAG capsulotomy is permitted).
- History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the opinion of the investigator, confound results.
- Current diagnosis of macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, or other chronic ocular conditions that would confound the study results.
- A current diagnosis of moderate or severe glaucoma.
- Patients with strabismus, forme fruste keratoconus, keratoconus or other corneal pathologies that would confound visual acuity measurement.
- Previous radial keratotomy (RK).
- Previous corneal keratoplasty (e.g., corneal transplant, Descemet's stripping automated endothelial keratoplasty (DSAEK), lamellar keratoplasty).
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy).
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate under mesopic/scotopic conditions).
- Capsular or zonular abnormalities or other conditions that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome).
- Usage of contact lenses during study participation.
- Concurrent participation in another device investigation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502
Mishael Benjamin, 434-528-2020, MBenjamin@piedmonteye.com
James Paauw, MD
- Recruiting
Berkeley Eye Center
Sugar Land, Texas, 77478
Tetiana Huff, 281-944-2251 ext. 2262, tetiana.huff@berkeleyeye.com
Morgan Micheletti, MD
About this study
Official title: EPIC: Evaluation of the Postoperative Cataract Surgery Outcomes in Patients With Prior Corneal Laser Vision Correction Implanted With the CT LUCIA Intraocular Lens Protocol GPAS-SAS-023-4
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.
- Being tested
- CT LUCIA 621P Intraocular Lens Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT LUCIA 621P Intraocular Lens ImplantationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CT LUCIA 621P IOL Implantation Group | Subjects with prior myopic corneal laser vision correction undergoing bilateral cataract surgery implanted with the CT LUCIA 621P intraocular lens. All subjects will be followed prospectively to assess postoperative visual and refractive outcomes. Receives: Device: CT LUCIA 621P Intraocular Lens Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postoperatively
Median Prediction Error (PE)
The median difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Measured: 3 months postoperatively
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.
Measured: 3 months postoperatively
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.
Measured: 3 months postoperatively
Percentage of Eyes Within ±0.50 D of Predicted MRSE
The proportion of eyes achieving postoperative MRSE within ±0.50 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Measured: 3 months postoperatively
Percentage of Eyes Within ±1.00 D of Predicted MRSE
The proportion of eyes achieving postoperative MRSE within ±1.00 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Measured: 3 months postoperatively
Secondary outcomes (2)
Corrected Distance Visual Acuity (CDVA)
Monocular and binocular postoperative corrected distance visual acuity measured by standard methods.
Measured: 3 months postoperatively
Uncorrected Distance Visual Acuity (UDVA)
Monocular and binocular postoperative uncorrected distance visual acuity.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084545
- Sponsor's protocol ID
- GPAS-SAS-023-4
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPIC: Evaluation of the Postoperative Cataract Surgery Outcomes in Patients With Prior Corneal Laser Vision Correction Implanted With the CT LUCIA Intraocular Lens Protocol GPAS-SAS-023-4
- ClinicalTrials.gov ID
- NCT07084545
- Acronym / sponsor ID
- GPAS-SAS-023-4
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT LUCIA 621P IOL Implantation Group | – | Device: CT LUCIA 621P Intraocular Lens ImplantationSubjects with prior myopic corneal laser vision correction undergoing bilateral cataract surgery implanted with the CT LUCIA 621P intraocular lens. All subjects will be followed prospectively to assess postoperative visual and refractive outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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).
- No visual acuity limiting corneal or retinal pathologies.
Key exclusion criteria (18 listed)
- 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.
- Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT LUCIA 621P Intraocular Lens ImplantationThe 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. | Device | CT LUCIA 621P IOL Implantation Group |
Primary outcome
Mean Prediction Error (PE)
Time frame: 3 months postoperatively
The average difference between postoperative manifest refraction spherical equivalent (MRSE) and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Median Prediction Error (PE)
Time frame: 3 months postoperatively
The median difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Absolute Prediction Error (PE)
Time frame: 3 months postoperatively
The absolute value of the difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Percentage of Eyes Within ±0.25 D of Predicted MRSE
Time frame: 3 months postoperatively
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.
Percentage of Eyes Within ±0.50 D of Predicted MRSE
Time frame: 3 months postoperatively
The proportion of eyes achieving postoperative MRSE within ±0.50 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
Percentage of Eyes Within ±1.00 D of Predicted MRSE
Time frame: 3 months postoperatively
The proportion of eyes achieving postoperative MRSE within ±1.00 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula.
2 secondary outcomes
Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months postoperatively
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction, run by Carl Zeiss Meditec AG at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Heering (949-293-0520, henry.heering@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Prediction Error (PE) (time frame: 3 months postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.