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Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery (ORAPSCA)

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract focused on measuring Cataract, Anisometropia, Aniseikonia Tolerance Range

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet - GlostrupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Multifocal

Mono-vision

Minimono-vision

Monofocal

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerance of anisometropia
Investigate if the tolerance of anisometropia is better in the elderly population compared to a younger population (SMILE patients). This will be evaluated by questionnaires and objective measurements as described.
Aniseikonia tolerance range (ATR)
Compare ATR in all four arms and in a SMILE population to investigate if ATR is a future screening tool that can predict which patients cannot tolerate anisometropia
Aniseikonia tolerance range (ATR)
Investigate if ATR is reproducible and clinical useful in cataract patients with poor vision
Anisometropia
Investigate if anisometropia > 3 diopters are better tolerated than previously described. This will be evaluated by questionnaires and objective measurements as described.

Full Information

First Posted
August 3, 2021
Last Updated
October 25, 2021
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05001932
Brief Title
Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery
Acronym
ORAPSCA
Official Title
Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
August 4, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Anisometropia, Aniseikonia Tolerance Range

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multifocal
Arm Type
Active Comparator
Arm Description
Patients will receive a multifocal lens bilateral (Alcon Vivity).
Arm Title
Mono-vision
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimono-vision
Arm Type
Active Comparator
Arm Description
Patients will receive a monofocal lens bilateral. Target refraction for the dominant eye will be -0.25D and for the non-dominant -1.25D.
Arm Title
Monofocal
Arm Type
Active Comparator
Arm Description
Patients will receive a monofocal lens bilateral. Target refraction will be -0.25D.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Randomized Clinical Trial
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Tolerance of anisometropia
Description
Investigate if the tolerance of anisometropia is better in the elderly population compared to a younger population (SMILE patients). This will be evaluated by questionnaires and objective measurements as described.
Time Frame
120 days
Title
Aniseikonia tolerance range (ATR)
Description
Compare ATR in all four arms and in a SMILE population to investigate if ATR is a future screening tool that can predict which patients cannot tolerate anisometropia
Time Frame
120 days
Title
Aniseikonia tolerance range (ATR)
Description
Investigate if ATR is reproducible and clinical useful in cataract patients with poor vision
Time Frame
120 days
Title
Anisometropia
Description
Investigate if anisometropia > 3 diopters are better tolerated than previously described. This will be evaluated by questionnaires and objective measurements as described.
Time Frame
120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Guldhammer Skov, MD
Phone
+45 38 63 38 63
Email
anne.guldhammer.skov.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten la Cour, MD, prof.
Organizational Affiliation
Rigshospitalet, Glostrup
Official's Role
Study Director
Facility Information:
Facility Name
Rigshospitalet - Glostrup
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Guldhammer Skov, MD
Phone
+4538634707
Email
anne.guldhammer.skov.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Refractive Results and Patient Satisfaction After Cataract Surgery

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