Evaluation of a low-energy femtosecond laser in cataract surgery

Completed

• Conditions: Cataract; Eye Diseases; Nuclear sclerosis grade 2 and grade 3

• Registration Number: ISRCTN53731135
• Lead Sponsor: Institute of Ophthalmology, University of Modena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 24 September 2018
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Over 50 years of age
2. Nuclear sclerosis grade 2 and 3 in the Lens Opacities Classification System III (LOCS III)

Exclusion Criteria

1. Previous eye surgery
2. Complicated cataracts (e.g. hard cataracts, traumatic cataracts, pseudoesfoliation syndrome)
3. Insufficient mydriasis (less than 4 mm)
4. Concomitant eye pathologies (uveitis, glaucoma, corneal opacities, diabetic retinopathy)
5. Low endothelial cell count (less than 1500 cells/mm²)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following outcomes measured at the baseline, 7 days, 1 month and 3 month follow-up:<br>1. Best corrected visual acuity (BCVA)<br>2. Corneal astigmatism<br>3. Central corneal thickness (CCT)<br>4. Endothelial cell count (ECC)<br>5. Central macular thickness (CMT)<br>6. Macular pigment optical density (MPOD)

Secondary Outcome Measures

Name	Time	Method
The following outcomes measured at the 18 month long term follow-up:<br>1. Intraoperative parameters<br>2. Intra- and post-operative complications<br>3. Posterior capsule opacification<br>4. Capsulorhexis shape