The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living

NCT05359380 | Completed

• 1 other identifier: ES1/Th1/08-02-2018
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and light temperature) for 10 activities of daily living (ADLs) that require near or intermediate vision acuity in a validated ADL simulation framework for a sample of patients who underwent presbyopic correction with bilateral multifocal intraocular lenses (IOLs) implantation, and to compare their capacity to perform ADLs (ADL scores) between three study groups (SG): SG1. patients implanted bilaterally with trifocal diffractive IOLs, SG2. patients implanted bilaterally with bifocal hybrid (diffractive-refractive) IOLs, SG3. patients implanted bilaterally with monofocal IOLs

Conditions

Presbyopia; Near Vision; Reading; Daily Activities; Multifocal Intraocular Lens; Cataract

Keywords

activities of daily living; presbyopia; light temperature; light intensity; multifocal intraocular lens

Outcome Measures

Primary Outcomes (10)

• Phone Book Search (PBS) score

  Patient is required to find and read a specific entry in a regular phonebook catalog in the nine different combinations of light temperature and light intensity. A different entry is asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Supermarket Receipt (SupRe) score

  Patient is required to find and read three products from a typical supermarket receipt in the nine different combinations of light temperature and light intensity. Different products are asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Book Reading (BR) score

  Patient is required to read an excerpt of a predetermined length in a novel in the nine different combinations of light temperature and light intensity. A different excerpt of the same length is asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Cellular message (CM) score

  Patient is required to read a Short Message Service (SMS) on a cellular phone in the nine different combinations of light temperature and light intensity. A different SMS is asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Cellular Entry Search (CES) score

  Patient is required to find and read one specific entry on a cellular phone in the nine different combinations of light temperature and light intensity. Different entries are asked to be found in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Reading Computer Screen (RCS) score

  Patient is required to correctly read text of a predetermined length from a computer screen in the nine different combinations of light temperature and light intensity. Different texts of the same length are asked to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Drops bottle Reading (DR) score

  Patient is required to correctly read the expiration date printed on three typical eye dropper bottles in the nine different combinations of light temperature and light intensity. Different eye dropper bottles are given to be read in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Subtitles Reading (SubRe) score

  Patient is required to correctly read movie subtitles from a one-minute movie excerpt on a computer screen in the nine different combinations of light temperature and light intensity. Different movie excerpts are shown in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Open Door Test (ODT) score

  Patient is required to find a specific key from a keychain that holds 10 keys and put it in the corresponding door keyhole in the nine different combinations of light temperature and light intensity. Different keychains are given in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

• Screwdriver Test (ST) score

  Patient is required to select one among three screwdrivers and insert it in the appropriate screw among a variety of screw types in the nine different combinations of light temperature and light intensity. Different screwdrivers are given to be selected in each combination. \[scale's best value: 100, scale's worst value: 0\]

  through study completion, an average of 6 months

Secondary Outcomes (5)

• Uncorrected Distance Visual Acuity (UDVA)

  through study completion, an average of 6 months

• Uncorrected Intermediate Visual Acuity (UIVA)

  through study completion, an average of 6 months

• Uncorrected Near Visual Acuity (UNVA)

  through study completion, an average of 6 months

• 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) score

  through study completion, an average of 6 months

• Subjective preference of lighting combination

  through study completion, an average of 6 months

Study Arms (3)

SG1 - Trifocal Group

Patients implanted bilaterally with trifocal diffractive IOLs

Other: ADL performance

SG2 - Bifocal Group

Patients implanted bilaterally with bifocal hybrid (diffractive - refractive) IOLs

Other: ADL performance

SG3 - Monofocal Group

Patients implanted bilaterally with monofocal IOLs

Other: ADL performance

Interventions

ADL performance OTHER

ADL performance All study groups address the following 10 ADL tasks in 9 different combinations of light temperature and light intensity in order possible differences to be revealed among the study groups and light combinations: 1\. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST). The 9 light combinations are the following: 3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc / 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc / 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc

SG1 - Trifocal Group; SG2 - Bifocal Group; SG3 - Monofocal Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients underwent phacoemulsification and bilateral implantation of IOLs \[SG1: trifocal diffractive IOL, SG2: bifocal hybrid (diffractive - refractive) IOL, SG3: monofocal IOL\]

You may qualify if:

• Age older than 18 years old
• Diagnosis of senile cataract either stage 2 or 3 of the Lens Opacities Classification System III (LOCS-3) grading scale - Patients underwent phacoemulsification and bilateral implantation of IOLs \[trifocal diffractive, bifocal hybrid (diffractive - refractive) or monofocal\]
• Fluency in written and verbal Greek language
• No severe cognitive impairment

You may not qualify if:

• Αstigmatism \>1.00 diopters
• Glaucoma
• Intraocular pressure-lowering medications
• Corneal pathology
• Fundus pathology
• Diabetes mellitus
• Autoimmune diseases
• Former incisional eye surgery
• Posterior capsule rupture or lens misalignment
• Neurological, psychiatric or mental diseases that interfere with visual acuity and reading process
• Inability to understand the objectives of the study

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (3)

• Labiris G, Panagiotopoulou EK, Ntonti P. Development and Validation of a Lighting Facility for the Objective Assessment of the Visual Performance of Presbyopic Patients in a Series of Activities of Daily Living. Cureus. 2022 Apr 28;14(4):e24548. doi: 10.7759/cureus.24548. eCollection 2022 Apr.

  PMID: 35651385 BACKGROUND

• Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.

  PMID: 34866900 BACKGROUND

• Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.

  PMID: 34588763 BACKGROUND

MeSH Terms

Conditions

Presbyopia; Myopia; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Georgios Labiris

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: September 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: September 15, 2022
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

GR (1)