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Evaluation of a low-energy femtosecond laser in cataract surgery

Evaluation of bimanual femtosecond laser-assisted cataract surgery with low energy LDV Z8

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53731135
Enrollment
20
Registered
2018-08-07
Start date
2016-01-01
Completion date
Unknown
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Eye Diseases Nuclear sclerosis grade 2 and grade 3

Interventions

After provision of written informed consent, consecutive patients with nuclear sclerosis grade 2 and 3 in the Lens Opacities Classification System III and in line for cataract surgery on the day in wh

Sponsors

Institute of Ophthalmology, University of Modena
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
The following outcomes measured at the 18 month long term follow-up: 1. Intraoperative parameters 2. Intra- and post-operative complications 3. Posterior capsule opacification 4. Capsulorhexis shape

Countries

Italy

Contacts

Public ContactGian Maria Cavallini

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026