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Cataract SurgeryNCT07288086

Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System

A study testing Preloaded intraocular lens system in people with Cataract Surgery and Intraocular Lens, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cataract Surgery, Intraocular Lens
What is being tested?
Preloaded intraocular lens system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 May 2025to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults of either sex.
  • 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.

Who cannot join

  • Irregular corneal astigmatism (e.g., keratoconus).
  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University Istanbul Medical Faculty Ophthalmology Department

    Istanbul, Fatih, 34250

Other trials in Turkey (Türkiye)

About this study

Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery

Read the detailed description

In this prospective and single-center clinical study, the safety and efficacy of the Enova PGF3 intraocular lens (IOL) and cartridge injector system will be evaluated.

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.

Being tested
Preloaded intraocular lens system
Keywords
cataract surgery, intraocular lens, preloaded intraocular lens, Enova

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preloaded intraocular lens systemDevice

    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.

Study groups in NCT07288086
Study groupRoleWhat they receive
Patients who need cataract surgeryExperimentalParticipants 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.
Receives: Device: Preloaded intraocular lens system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions

    Proportion of eyes achieving 20/20 or better uncorrected distance visual acuity under photopic conditions.

    Measured: 1 month postoperatively

  2. Subjective Refractive Error

    Eyes with a postoperative refractive error within ±0.50 diopters of the intended target.

    Measured: 1 month postoperatively

  3. Overall Clinical Performance of the Preloaded IOL System

    Surgeon-rated assessment of the general clinical performance of the preloaded system by The ENOVA PGF3 Questionnaire. This questionnaire is a 14-item, study-specific, non-validated survey developed to evaluate surgeons' experience with an intraocular lens (IOL) preloaded delivery system. Eleven items are rated on a 5-point Likert scale with the following scoring structure:

    1. = Low
    2. = Below Expectation
    3. = Meets Expectation
    4. = Above Expectation
    5. = Outstanding Performance

    Some additional items are Yes/No questions and do not contribute to the numerical total score.

    The total numerical score is calculated by summing the 11 Likert-scaled items. Total score range: 11 to 55, with higher scores indicating better performance and more favorable user experience.

    Measured: 1 month after surgery

Secondary outcomes (2)

  1. Preloaded System Evaluation Patient Questionnaire

    Patient-reported outcomes assessing whether expectations for visual improvement and overall satisfaction were met.The questionnaire consists of 14 items assessing a patient's self-reported difficulty in performing vision-related daily activities. Each activity is rated using a 0-4 scale, where:

    4 = No difficulty

    3 = Mild difficulty

    2 = Moderate difficulty

    1 = Severe difficulty

    0 = Unable to perform the activity

    The total score is calculated by summing responses across all 14 items. Total possible score range: 0 to 56

    Higher scores indicate better visual function and less activity limitation.

    Lower scores indicate worse visual function.

    Measured: Baseline (preoperative) and 1 month postoperatively

  2. Surgical Procedure Assessment

    Surgeon-reported ease of lens implantation and accuracy of lens placement, evaluating whether expectations for procedural handling were met.The surgeon notes, during the operative visit, the location of the incision, the size of the incision, whether the implantation system is compatible with the wound site, how many seconds the implantation time is shortened, and whether there were any issues with the unfolding of the intraocular lens or its placement into the capsular bag.

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start10 May 2025
  3. Primary completion1 Jun 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288086
Sponsor's protocol ID
IstanbulUni
Status last verified
Nov 2026
First submitted
26 Aug 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data will not be shared outside the study.

Publications

  • 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.

    PubMed 30853318

  • 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.

    PubMed 36453335

  • 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.

    PubMed 30008971

Questions about this trial

What is this clinical trial studying?

A study testing Preloaded intraocular lens system in people with Cataract Surgery and Intraocular Lens, run by Istanbul University at 1 site in Turkey (Türkiye).

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 17 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions (time frame: 1 month postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288086, which also lists 3 linked publications.

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 4 Nov 2026.

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