Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery

NCT05001932 | Unknown

• 1 other identifier: H 18058722
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

Cataract; Anisometropia; Aniseikonia Tolerance Range

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Investigate if MIOLs, mono-vision and mini-vision provides better visual function, quality of vision and spectacle free vision compared to monofocal IOLs. This will be evaluated by questionnaires and objective measurements as described.

  120 days

Secondary Outcomes (4)

• Tolerance of anisometropia

  120 days

• Aniseikonia tolerance range (ATR)

  120 days

• Aniseikonia tolerance range (ATR)

  120 days

• Anisometropia

  120 days

Study Arms (4)

Multifocal

ACTIVE COMPARATOR

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

Procedure: Cataract surgery

Mono-vision

ACTIVE COMPARATOR

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.

Procedure: Cataract surgery

Minimono-vision

ACTIVE COMPARATOR

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

Procedure: Cataract surgery

Monofocal

ACTIVE COMPARATOR

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

Procedure: Cataract surgery

Interventions

Cataract surgery PROCEDURE

Randomized Clinical Trial

Minimono-vision; Mono-vision; Monofocal; Multifocal

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet - Glostrup

Copenhagen, Glostrup, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Cataract; Anisometropia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Morten la Cour, MD, prof.

  Glostrup University Hospital, Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Anne Guldhammer Skov, MD

CONTACT

+45 38 63 38 63; anne.guldhammer.skov.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 12, 2021
• Study Start: August 11, 2021
• Primary Completion: August 4, 2023
• Study Completion: June 1, 2024
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)