Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery

Not Applicable

• Conditions: Cystoid Macular Edema; Age Related Cataracts
• Interventions: Other: Manual Cataract Surgery; Device: Femtosecond Laser

• Registration Number: NCT03465124
• Lead Sponsor: Medical University of Vienna

Brief Summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Study Start: 2018-03-26
• Primary Completion: 2019-02-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Study Completion: 2019-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Bilateral Age-related cataract necessitating lens extraction and posterior IOL implantation
• Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

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Exclusion Criteria

• Corneal abnormality
• Preceding ocular surgery or trauma
• Uncontrolled glaucoma
• Proliferative diabetic retinopathy
• Macular degeneration
• Iris neovascularization
• History of uveitis/iritis
• Microphthalmus
• Recurrent intraocular inflammation of unknown etiology
• Blind fellow eye
• Uncontrolled systemic or ocular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Cataract Surgery	Manual Cataract Surgery	Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.
Femtosecond Laser assisted Cataract Surgery	Femtosecond Laser	Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.

Primary Outcome Measures

Name	Time	Method
Central Macular Thickness	Baseline to 6 weeks postoperative	Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)

Secondary Outcome Measures

Name	Time	Method
Influence of lens density on quantitative autofluorescence	Baseline to 1 weel, 3 weeks and 6 weeks postoperative	Influence of lens density on quantitative autofluorescence will be assessed in qAF units. Images will be recorded after volume scans for each eye on designated visits.; Quantitative Autofluorescence quantifies natural fundus autofluorescence with a Spectralis HRA+OCT. This method uses the same wavelength and confocal scanning laser ophthalmoscope as fundus autofluorescence (488nm; maximum power: 280 µW) and can be used to determine the integrity and vitality of the retinal pigment epithelium which is important for nourishment the retina.
Central Macular Thickness	Baseline to 1 week, 3 weeks, 6 weeks postoperative	Difference in Central Macular Thickness (CMT) between Femtosecond Laser-assisted Cataract Surgery (LCS) to Manual Cataract Surgery (MCS)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria