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

NCT07288086 | Active Not Recruiting

• 1 other identifier: IstanbulUni
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraocular Lens; Cataract Surgery

Keywords

cataract surgery; intraocular lens; preloaded intraocular lens; Enova

Outcome Measures

Primary Outcomes (3)

• Uncorrected Distance Visual Acuity (UDVA) - Photopic Conditions

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

  1 month postoperatively

• Subjective Refractive Error

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

  1 month postoperatively

• 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.

  1 month after surgery

Secondary Outcomes (2)

• Preloaded System Evaluation Patient Questionnaire

  Baseline (preoperative) and 1 month postoperatively

• Surgical Procedure Assessment

  Intraoperative

Other Outcomes (3)

• Serious Adverse Events

  1 month postoperatively

• Postoperative Inflammation

  1 week and 1 month postoperatively

• Intraocular Pressure,

  1 week and 1 month postoperatively

Study Arms (1)

Patients who need cataract surgery

EXPERIMENTAL

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.

Device: Preloaded intraocular lens system

Interventions

Preloaded intraocular lens system DEVICE

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.

Patients who need cataract surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty Ophthalmology Department

Istanbul, Fatih, 34250, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30853318 RESULT

• 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.

  PMID: 36453335 RESULT

• 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.

  PMID: 30008971 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: December 17, 2025
• Study Start: May 10, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TU (1)