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Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery

NCT ID: NCT05001932

Last Updated: 2021-11-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2024-06-01

Brief Summary

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Cataract surgery is the most common eye surgery in the world. If the patient with cataract uses spectacles and both patient and surgeon find it beneficial, it is possible to compensate for the spectacles during surgery and thereby obtain a spectacle-free distance vision or spectacle-free near vision. Becoming spectacle free increases quality of life substantially and is one of the primary wishes in cataract patients. Socioeconomically, spectacle free life is beneficial as it reduces fall tendency in the elderly population. Multifocal lenses warrant the possibility of obtaining a spectacle free vision at near, intermediate and distance. It is also possible to obtain spectacle free distance and near vision or distance and intermediate vision by using traditional artificial monofocal lenses but making one eye spectacle free for distance and the other eye spectacle free for near or intermediate vision. Currently, it is not know which procedure is most beneficial for cataract patients.

In a recent PhD, the investigators developed a method, Aniseikonia Tolerance Range (ATR), that can assess how much refractive change a patient can endure without impairing stereopsis. The results demonstrated large variation in the tolerance of image difference. This method can be a future tool to assess whether a patient can tolerate the refraction that is considered most beneficial to the patient. The knowledge is important as it can help avoid improper lens choice in cataract surgery and thereby avoid stereopsis problems.

Detailed Description

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Background This randomized clinical trial aims to improve visual outcomes in cataract surgery by examining which intraocular lenses (IOL)/operation methods that provide highest patient satisfaction, visual function and spectacle free vision. Furthermore, the tolerance of surgical induced refractive difference (anisometropia) will be examined and a screening method to assess how much anisometropia a patient can endure will be validated. The investigators will examine if the tolerance of anisometropia \> 3 diopters is better than previously described and examine if ATR can predict which patients will experience binocular problems if exposed to surgical induced aniseikonia.These results will lead to higher patient satisfaction, better visual outcomes with elimination of patients with mediocre refractive results and visual problems due to anisometropia.

In addition the investigators will examine whether ATR is reproducible by examining the variation in the multiple measurements and in a prospective study the investigators will investigate the inter and intra person reproducibility of ATR.

100 refractive patients with healthy eyes except myopia \> 3 diopters and \< 6 diopters, who will have a Small Incision Lenticule Extraction (SMILE) surgery will have all investigations done. The patients will have a bilateral SMILE with a interval of seven weeks and will in between the two procedures have a surgically introduced anisometropia that will provide further knowledge on anisometropia and ATR.

Conditions

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Cataract

Keywords

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Cataract Anisometropia Aniseikonia Tolerance Range

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Multifocal

Patients will receive a multifocal lens bilateral (Alcon Vivity).

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Randomized Clinical Trial

Mono-vision

Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant myopia of -2.50D.

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Randomized Clinical Trial

Minimono-vision

Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant -1.25D.

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Randomized Clinical Trial

Monofocal

Patients will receive a monofocal lens bilateral. Target refraction will be -0.25D.

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Randomized Clinical Trial

Interventions

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Cataract surgery

Randomized Clinical Trial

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Bilateral cataract
* Axial length: 20-27 mm
* ACD \> 2.3 mm
* Pupil size: ≥ 5.0 mm in dilatation
* Pupil siza: ≥ 2.5 mm in photo topic condition
* Stereoacuity ≤ 480 seconds of arch

Exclusion Criteria

* Former intraocular surgery
* Other eye disease (amblyopia, strabismus, corneal pathology, glaucoma, uveitis, age related maculopathy
* Other retinal diseases
* Risk of weak zonules due to PEX or former trauma
* Astigmatism ≥ 1.0 diopter
* Diabetes
* Axial length difference between the two eyes \> 0.3 mm
* Dementia
* Lack of cooperation kooperation
* Stereoacuity \> 480 seconds of arc
* Complicated cataract surgery or postoperative complications (intraocular infection, retinal detachment, macular edema
* Business driving
* Night driving
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anne Guldhammer Skov, MD

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten la Cour, MD, prof.

Role: STUDY_DIRECTOR

Rigshospitalet, Glostrup

Locations

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Rigshospitalet - Glostrup

Copenhagen, Glostrup, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anne Guldhammer Skov, MD

Role: CONTACT

Phone: +45 38 63 38 63

Email: [email protected]

Facility Contacts

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Anne Guldhammer Skov, MD

Role: primary

Other Identifiers

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H 18058722

Identifier Type: -

Identifier Source: org_study_id