For Doctors in a Hurry
- Surgeons lack a standardized, sutureless method for secondary intraocular lens fixation in eyes without adequate capsular or zonular support.
- This multicenter, prospective, first-in-human study evaluated a sutureless prosthetic capsular bag in 15 patients requiring secondary lens placement.
- Results showed a mean spherical equivalent of 0.12 diopters and one serious adverse event involving footplate re-internalization.
- The researchers concluded the device provides a viable platform for secure posterior scleral fixation without conjunctival erosion or lens dislocation.
- Clinicians may eventually use this device to simplify complex fixations, though additional studies must confirm these initial safety findings.
The Surgical Challenge of the Compromised Capsule
Managing patients with a lack of capsular support requires complex reconstructive techniques to restore visual function and ocular anatomy [1, 2, 3]. Conditions such as severe ocular trauma or congenital anomalies frequently result in a complete loss of the zonular apparatus, leaving clinicians with few options for stable intraocular lens fixation [4, 5, 6]. While various suturing methods exist to address anterior segment dysgenesis (abnormal development of the front of the eye), these procedures are technically demanding and associated with long-term risks such as suture degradation or device displacement [7, 8, 9]. Current strategies often involve iris-fixated or scleral-sutured lenses, yet achieving predictable refractive outcomes in the absence of a stable capsular diaphragm remains a primary hurdle in secondary lens surgery [10]. To address this, a recent first-in-human investigation evaluates a sutureless strategy for establishing a secure intraocular lens platform using a scleral-fixated prosthetic capsular bag [11].
Design of the Scleral-Fixated Prosthetic Bag
The clinical evaluation of the prosthetic capsular bag was conducted as a multicenter, prospective, open-label, single-arm, exploratory, first-in-human investigation. To assess the safety and surgical viability of the device, researchers recruited 15 subjects from three specialized retina practices located in Sydney, Australia. Every participant entered the study with a clear clinical indication for secondary lens intervention, specifically characterized by insufficient capsular or zonular integrity to support a standard intraocular lens (IOL). This patient population represents a significant surgical challenge, as the lack of natural support structures typically necessitates complex suturing or iris-fixation techniques that are prone to long-term instability. The surgical protocol required each patient to undergo a pars plana vitrectomy (a procedure where the vitreous gel is removed to provide clear access to the posterior segment of the eye) alongside the removal of a dislocated crystalline lens or a previously displaced IOL. Following the vitrectomy, the prosthetic capsular bag was introduced into the eye using a standard IOL injector. This delivery system allowed the device to be inserted either alone or preloaded with a secondary IOL, streamlining the implantation process within the posterior chamber. Fixation of the device was achieved through a sutureless, trans-scleral method designed to minimize tissue trauma and reduce the risk of suture-related degradation. The prosthetic capsular bag was secured via three fixation arms that pass through the sclera (the white outer layer of the eyeball). Notably, this technique does not require the creation of scleral pockets or the use of permanent sutures, which are common points of failure in traditional secondary lens fixations. By utilizing these three integrated arms, the device establishes a stable, centrated platform for the IOL, effectively replacing the function of the natural zonular apparatus.
Safety Profile and Device Stability at 12 Months
The primary endpoints of the study focused on the incidence and characterization of adverse events related to the prosthetic capsular bag through 12 months postoperatively. Throughout this follow-up period, the device demonstrated high mechanical stability within the posterior chamber. Clinical evaluations confirmed that there were no cases of IOL dislocation from the prosthetic capsular bag, indicating that the device successfully maintained the position of the secondary lens without the need for traditional capsular support. Furthermore, the researchers reported no cases of conjunctival erosion over the footplates (the wearing away of the thin, clear membrane covering the white of the eye). This finding is particularly relevant for operating ophthalmologists, as conjunctival thinning and subsequent device exposure are frequent, sight-threatening complications associated with traditional trans-scleral fixation techniques. Despite the overall stability of the cohort, the study identified one device-related serious adverse event occurring in a patient with Marfan syndrome, a genetic connective tissue disorder that often results in weakened ocular structures. This individual experienced the re-internalization of a single footplate, a complication where the fixation arm of the device retracted from its trans-scleral position back into the interior of the eye. This event required secondary surgical intervention to re-fixate the footplate and restore the stability of the prosthetic bag. Aside from this single surgical revision, the sutureless fixation arms remained secure in the remaining subjects, suggesting that the three-point fixation system provides a reliable alternative for stabilizing lenses in eyes with profound zonular insufficiency.
Visual Acuity and Refractive Predictability
The functional outcomes of the prosthetic capsular bag demonstrate significant recovery of vision for patients with profound zonular insufficiency. On average, uncorrected visual acuity (UCVA) improved by 12 lines on a standard eye chart, representing a substantial gain in functional vision without the need for external correction. Furthermore, 71% of subjects achieved a UCVA within 2 lines of their screening best corrected visual acuity (BCVA), which refers to the maximum vision attainable with corrective lenses. These results suggest that the device effectively centers the IOL along the visual axis, allowing for a high degree of visual rehabilitation in eyes that were previously aphakic or suffered from severely dislocated lenses. The study also highlights the stability and predictability of the refractive results achieved with this sutureless system. The researchers found that 93% of subjects maintained a BCVA within 1 line of their screening BCVA, indicating that the surgical intervention and the presence of the prosthetic bag did not negatively impact the eye's best potential vision. Regarding refractive precision, the prosthetic capsular bag provided a mean spherical equivalent of 0.12 diopters with a standard deviation of 0.39 D. The spherical equivalent (a calculation that collapses the cylinder and sphere of a prescription into a single number to represent the overall refractive power) is a critical metric for surgical planning. This low standard deviation and near-zero mean suggest high predictability for secondary lens placement, allowing clinicians to select IOL powers with greater confidence that the postoperative refractive target will be met.
References
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2. Desideri LF, Arun K, Doherty G, Bernardi E, Anguita R. Iris Reconstruction: A Surgeon’s Guide. Journal of Clinical Medicine. 2024. doi:10.3390/jcm13092706
3. Mayer CS, Hoffmann AM, Prahs P, Reznicek L, Khoramnia R. Functional outcomes after combined iris and intraocular lens implantation in various iris and lens defects. BMC Ophthalmology. 2020. doi:10.1186/s12886-020-01621-8
4. Romano D, Romano V, Daruich A, et al. Congenital aniridia: European COST action ANIRIDIA ‐ NET guidelines for diagnosis, management and care. Acta Ophthalmologica. 2025. doi:10.1111/aos.17587
5. Daruich A, Duncan MK, Robert MP, et al. Congenital aniridia beyond black eyes: From phenotype and novel genetic mechanisms to innovative therapeutic approaches. Progress in Retinal and Eye Research. 2022. doi:10.1016/j.preteyeres.2022.101133
6. Mikhail M, Koushan, Sharda, Isaza, Mann M. Traumatic aniridia in a pseudophakic patient 6 years following surgery. Clinical ophthalmology. 2012. doi:10.2147/opth.s25396
7. Weissbart SB, Ayres BD. Management of aniridia and iris defects: an update on iris prosthesis options.. Current opinion in ophthalmology. 2016. doi:10.1097/ICU.0000000000000253
8. Jakob-Girbig J, Salewsky S, Meller D. Use of the Ophtec Artificial Iris Model C1 in Patients with Aniridia/Aphakia. Klinische Monatsblätter für Augenheilkunde. 2021. doi:10.1055/a-1475-1049
9. Mayer CS, Laubichler AE, Khoramnia R, et al. Challenges and Complication Management in Novel Artificial Iris Implantation. Journal of Ophthalmology. 2018. doi:10.1155/2018/3262068
10. Mayer CS, Khoramnia R. “Double Prosthesis Implantation”: Biometry and Refractive Outcomes in Combined Intraocular Lens and Artificial Iris Surgery. Clinical ophthalmology. 2021. doi:10.2147/opth.s302224
11. Khadamy J. Harnessing the Underutilized Potential of Lens Capsule Transplantation in Ophthalmology: A Narrative Review of Current Applications and Future Directions. Cureus. 2025. doi:10.7759/cureus.82259
