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

NCT ID: NCT04072978

Last Updated: 2023-11-27

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2025-01-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Corneal Endothelial Cell Loss Secondary Intraocular Lens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraocular lens implantation: AC IOL

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

Intervention Type DEVICE

Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.

Intraocular lens implantation: SF IOL

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

Intervention Type DEVICE

Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.

Interventions

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Intraocular lens implantation

Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.

Intervention Type DEVICE

Other Intervention Names

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IOL implantation

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Kertes

Ophthalmologist - Retina Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Kertes, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Hospital

Locations

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Sunnybrook Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Cindy Rutz

Role: CONTACT

416 480 5091

Faryal Maniyali

Role: CONTACT

416 480 6100 ext. 2870

Facility Contacts

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Cindy Rutz

Role: primary

416 480 5091

Faryal Maniyali

Role: backup

416 480 6100 ext. 2870

References

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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.

Reference Type BACKGROUND
PMID: 25448990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30298105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17070590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29219957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28457613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28410720 (View on PubMed)

Other Identifiers

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00046460

Identifier Type: -

Identifier Source: org_study_id