NCT02403206

Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

Completed NA Results posted Last updated 2 July 2018

What this trial tests

NA trial testing Femtosecond laser in Intumescent Cataract in 406 participants. Completed in 24 August 2016.

Timeline

26 March 2015

Primary endpoint
12 July 2016

24 August 2016

Quick facts

Lead sponsor	Alcon, a Novartis Company
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	406
Start date	26 March 2015
Primary completion	12 July 2016
Estimated completion	24 August 2016

Drugs / interventions tested

• Femtosecond laser
• Continuous Curvilinear Capsulorhexis (CCC)

Conditions studied

• Intumescent Cataract — all drugs for Intumescent Cataract →

Sponsor

Alcon, a Novartis Company — full company profile →

Who can join

21 and older, any sex, with Intumescent Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Capsular Tears (Anterior or Posterior) During Surgery Primary · Day 0 (operative day)

A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.

Group	Value	95% CI
Laser (LSX)	5.3
Manual (CCC)	5.3

Operating Time in the Eye to Complete Entire Cataract Procedure Secondary · Day 0 (operative day)

Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.

Group	Value	95% CI
Laser (LSX)	795.0	± 354.7
Manual (CCC)	856.6	± 436.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pretreatment

Serious: 1/406 (0%)

Deaths: 0/406

Laser (LSX)

Serious: 16/188 (9%)

Deaths: 0/188

Manual (CCC)

Serious: 14/191 (7%)

Deaths: 0/191

Serious adverse events (16 terms)

Reaction	System	Pretreatment	Laser (LSX)	Manual (CCC)
Procedural complication	Injury, poisoning and procedural complications	—	—	—
Posterior capsule rupture	Eye disorders	—	—	—
Vitrectomy	Surgical and medical procedures	—	—	—
Vitreous loss	Eye disorders	—	—	—
Eye operation	Surgical and medical procedures	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Aphakia	Eye disorders	—	—	—
Iridocele	Eye disorders	—	—	—
Iris adhesions	Eye disorders	—	—	—
Iris atrophy	Eye disorders	—	—	—
Retinal detachment	Eye disorders	—	—	—
Cataract operation complication	Injury, poisoning and procedural complications	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Glaucoma surgery	Surgical and medical procedures	—	—	—
Intraocular lens implant	Surgical and medical procedures	—	—	—
Retinopexy	Surgical and medical procedures	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Pretreatment	Laser (LSX)	Manual (CCC)
Corneal oedema	Eye disorders	—	—	—
Corneal disorder	Eye disorders	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—
Ocular hypertension	Eye disorders	—	—	—

Most-reported serious reactions: Procedural complication, Posterior capsule rupture, Vitrectomy, Vitreous loss, Eye operation, Myocardial infarction, Aphakia, Iridocele.

Data from ClinicalTrials.gov NCT02403206 adverse events section.

Sponsor's own description

The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery.
   Day AC, Gore DM, Bunce C, Evans JR. · · 2016 · cited 74× · PMID 27387849 · DOI 10.1002/14651858.cd010735.pub2
2. Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery.
   Narayan A, Evans JR, O'Brart D, Bunce C, et al · · 2023 · cited 24× · PMID 37369549 · DOI 10.1002/14651858.cd010735.pub3