Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System
NCT ID: NCT07288086
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-10
2026-03-10
Brief Summary
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Detailed Description
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The Enova PGF3 cartridge injector system is designed to be used in cataract surgeries. Cataract patients aged 40 years and older, both male and female, without any serious ocular disease other than cataracts, will undergo IOL implantation following cataract surgery. It is planned to perform a total of 200 implantations with either unilateral or bilateral implantation of the participants' eyes.
Postoperative visual acuity, refraction, patient satisfaction, and adverse events will be monitored during follow-up visits at day 1, week 1, and month 1.
The primary objectives of the study are to achieve an uncorrected distance visual acuity of 20/20 or better, and to maintain an error and complication rate related to the preloaded system below 7.5%. Secondary objectives include evaluating patient satisfaction and assessing whether surgeons find the preloaded system easy to use and if it meets their expectations.
The primary endpoints are refractive stability within ±0.50 D, uncorrected distance visual acuity of 20/20 or better, and a general clinical performance rating of the preloaded system with a score of 95% or higher. Secondary endpoints include the duration of surgery, accuracy of lens positioning, surgical complications, surgeon-reported ease of use, and patient satisfaction survey results meeting expectations.
As a safety parameter, adverse events reported in postoperative surgical reports will be evaluated.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients who need cataract surgery
Participants will undergo standard cataract surgery using the new preloaded intraocular lens (IOL) system. The intervention involves implantation of the preloaded IOL following routine phacoemulsification techniques.
Preloaded intraocular lens system
This intervention uses a preloaded IOL delivery system, which allows for a single-use, sterile implantation during standard phacoemulsification cataract surgery. Unlike standard manually loaded IOLs, this system reduces preparation time and minimizes handling of the lens, potentially improving surgical efficiency and maintaining lens sterility.
Interventions
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Preloaded intraocular lens system
This intervention uses a preloaded IOL delivery system, which allows for a single-use, sterile implantation during standard phacoemulsification cataract surgery. Unlike standard manually loaded IOLs, this system reduces preparation time and minimizes handling of the lens, potentially improving surgical efficiency and maintaining lens sterility.
Eligibility Criteria
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Inclusion Criteria
Age 40 years or older.
Willing and able to provide written informed consent and comply with planned study visits and procedures.
Healthy ocular status, with no ocular pathology other than cataract and mild refractive error.
Potential visual acuity of 20/32 (0.2 logMAR) or better in both eyes.
Presence of regular corneal astigmatism suitable for treatment with the study device.
Candidates for uncomplicated cataract surgery using the study device.
Exclusion Criteria
Corneal pathology (e.g., scar, dystrophy, pterygium, moderate to severe dry eye).
Monocular conditions (e.g., amblyopia).
Previous corneal surgery, including radial keratotomy, corneal refractive surgery, corneal transplantation, DSAEK, or lamellar keratoplasty.
Previous anterior or posterior segment surgery (e.g., vitrectomy, laser iridotomy).
Diabetic retinopathy.
Macular pathology (e.g., age-related macular degeneration \[ARMD\], epiretinal membrane \[ERM\]).
History of retinal detachment.
Surgical complications that may affect study outcomes, such as:
Decentration due to capsulorhexis issues
Improper lens placement
Inadequate or missing postoperative capsular support
Posterior capsular rupture
Vitreous loss
Iris damage (tear, rupture, etc.)
Acute or chronic ocular diseases known to affect visual acuity or study outcomes (e.g., immunosuppressed state, connective tissue disease, clinically significant atopic disease, diabetes, or other systemic or ocular conditions).
Participation in any investigational drug or device study within 30 days prior to study start, or ongoing participation in another study.
40 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Semih Çakmak
Assistant Professor
Locations
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Istanbul University Istanbul Medical Faculty Ophthalmology Department
Istanbul, Fatih, Turkey (Türkiye)
Countries
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References
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Oshika T, Wolfe P. In vitro comparison of delivery performance of 4 preloaded intraocular lens injector systems for corneal and sclerocorneal incisions. J Cataract Refract Surg. 2019 Jun;45(6):840-846. doi: 10.1016/j.jcrs.2018.10.050. Epub 2019 Mar 8.
Joshi RS. Comparative evaluation of an automated preloaded delivery system with a non-preloaded system. Indian J Ophthalmol. 2022 Dec;70(12):4307-4311. doi: 10.4103/ijo.IJO_1635_22.
Acar B, Torun IM, Acar S. Evaluation of Preloaded IOL Delivery System and Hydrophobic Acrylic Intraocular Lens in Cataract Surgery. Open Ophthalmol J. 2018 Jun 14;12:94-103. doi: 10.2174/1874364101812010094. eCollection 2018.
Other Identifiers
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IstanbulUni
Identifier Type: -
Identifier Source: org_study_id