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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03465124
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Cataracts; Cystoid Macular Edema	Device: Femtosecond Laser; Other: Manual Cataract Surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).Bilateral cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either Femtosecond Laser assisted Cataract Surgery (LCS) or conventional Manual Cataract Surgery (MCS).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before procedure start.
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Central Macular Thickness in Femtosecond Laser-assisted Cataract Surgery - FLAME
• Actual Study Start Date: Mar 26, 2018
• Actual Primary Completion Date: Feb 19, 2019
• Anticipated Study Completion Date: Apr 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Femtosecond Laser assisted Cataract Surgery Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order.	Device: Femtosecond Laser; Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
Active Comparator: Manual Cataract Surgery Manual Cataract Surgery will be performed in contralateral (to LCS) eye of patient with bilateral age-related cataract.	Other: Manual Cataract Surgery; conventional cataract surgery as control

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Rupert Menapace, MD, Medical Universitiy of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rupert Menapace, Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT03465124
• Other Study ID Numbers: 1053/2018
• First Posted: Mar 14, 2018
• Last Update Posted: Mar 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Macular Edema

Study Results

No Results Posted as of Mar 7, 2019