Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

NCT04072978 — Unknown, 60 participants, Sunnybrook Health Sciences Centre

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Registry	NCT04072978
Status	Unknown
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Sunnybrook Health Sciences Centre (Other)
Conditions	Corneal Endothelial Cell Loss, Secondary Intraocular Lens
Interventions	Intraocular lens implantation (Device)
Dates	start 2019-09-01, primary completion 2024-12-30 (estimated), completion 2025-01-30 (estimated), first posted 2019-08-28, last updated 2023-11-27
Locations	1 site in Canada

-Summary

This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).

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+Detailed description

On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.

+Arms and interventions

Arm	Type	Interventions	Description
Intraocular lens implantation: AC IOL		Device: Intraocular lens implantation	Patients who are scheduled to undergo AC IOL (anterior chamber intraocular lens) implantation for any of the following indications: * primary or secondary aphakia * primary or secondary lens subluxation or dislocation
Intraocular lens implantation: SF IOL		Device: Intraocular lens implantation	Patients who are scheduled to undergo SF IOL (scleral fixated intraocular lens) implantation for any of the following indications: * primary or secondary aphakia * primary or secondary lens subluxation or dislocation

Intraocular lens implantation (Device), also known as IOL implantation: Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.

+Outcome measures

Primary outcomes

Endothelial cell loss [Pre-operative (baseline) and 24 weeks post-operatively.]: Change in endothelial cell count from baseline compared to 24 months post-operatively.

Secondary outcomes

Corrected distance visual acuity (CDVA) [Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.]: CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Other outcomes

Secondary adverse events (SAE's) [Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.]: Occurrence of cystoid macular edema (CME), retinal detachment, UGH syndrome, vitreous or choroidal hemorrhage, lens subluxation/ dislocation, glaucoma, uveitis, etc.

+Eligibility

Sex: All, ages: 16 Years to 99 Years, accepts healthy volunteers

Inclusion Criteria:

1. Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange).
2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
3. Decision makers able to provide informed consent.

Exclusion Criteria:

1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
2. Patients unable to attend follow-up visits.
3. Patients who have had a corneal transplant prior to secondary IOL implantation.

+Locations (1)

Facility	City	Country	Status
Sunnybrook Hospital	Toronto, Ontario	Canada	Recruiting

+Publications

Chan TC, Lam JK, Jhanji V, Li EY. Comparison of outcomes of primary anterior chamber versus secondary scleral-fixated intraocular lens implantation in complicated cataract surgeries. Am J Ophthalmol. 2015 Feb;159(2):221-6.e2. doi: 10.1016/j.ajo.2014.10.016. Epub 2014 Oct 22. PMID 25448990
Krysik K, Dobrowolski D, Wroblewska-Czajka E, Lyssek-Boron A, Wylegala E. Comparison of the Techniques of Secondary Intraocular Lens Implantation after Penetrating Keratoplasty. J Ophthalmol. 2018 Sep 12;2018:3271017. doi: 10.1155/2018/3271017. eCollection 2018. PMID 30298105
Kwong YY, Yuen HK, Lam RF, Lee VY, Rao SK, Lam DS. Comparison of outcomes of primary scleral-fixated versus primary anterior chamber intraocular lens implantation in complicated cataract surgeries. Ophthalmology. 2007 Jan;114(1):80-5. doi: 10.1016/j.ophtha.2005.11.024. Epub 2006 Oct 27. PMID 17070590
Negretti GS, Lai M, Petrou P, Walker R, Charteris D. Anterior chamber lens implantation in vitrectomised eyes. Eye (Lond). 2018 Mar;32(3):597-601. doi: 10.1038/eye.2017.261. Epub 2017 Dec 8. PMID 29219957
Yamane S, Sato S, Maruyama-Inoue M, Kadonosono K. Flanged Intrascleral Intraocular Lens Fixation with Double-Needle Technique. Ophthalmology. 2017 Aug;124(8):1136-1142. doi: 10.1016/j.ophtha.2017.03.036. Epub 2017 Apr 27. PMID 28457613
Brunin G, Sajjad A, Kim EJ, Montes de Oca I, Weikert MP, Wang L, Koch DD, Al-Mohtaseb Z. Secondary intraocular lens implantation: Complication rates, visual acuity, and refractive outcomes. J Cataract Refract Surg. 2017 Mar;43(3):369-376. doi: 10.1016/j.jcrs.2016.12.024. PMID 28410720

+Investigators

Peter Kertes, MD, Principal investigator, Sunnybrook Hospital