Assesment of Intermediate Vision After BIL Cataract Surgery

Cataract Clinical Trial

Official title:

Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364761
• Other study ID #: 24103_BIL_EDOF
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Jorgos Koulalis, M.D.
• Phone: +32474045858
• Email: jorkoul[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".

The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.

Participants will:

• Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)

• Have to fill in 2 questionnaires about visual functioning and spectacle independance

Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of at least 18 years old

• Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion

• Must not meet any exclusion criteria

Exclusion Criteria:

• Prior refractive surgery (other than bag in the lens)

• Glaucoma

• Corneal opacities

• Moderate non proliferative diabetic retinopathy or worse

• Optic neuropathy

• History of uveitis

• Amblyopia

• Residual post-operative astigmatism higher than 1.5 Diopters (D)

• Best corrected visual acuity < 1.0

• Patients unable to cooperate or sign the informed consent

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Bag in the lens cataract surgery
Cataract surgery using the Morcher 89A intraocular lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermediate vision	uncorrected and distance corrected intermediate vision at 66cm in LogMAR	During the only hospital visit required in the study, between april and december 2024
Secondary	Near vision	uncorrected and distance corrected intermediate vision at 40cm in LogMAR	During the only hospital visit required in the study, between april and december 2024