Intumescent Cataract
Conditions
Brief summary
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.
Interventions
DEVICEFemtosecond laser
Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
PROCEDUREContinuous Curvilinear Capsulorhexis (CCC)
Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to undergo cataract surgery. * Able to lie flat in a supine position. * Able to understand and willing to sign the Informed Consent Form (ICF). * Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Pregnant or lactating mothers. * Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength. * Corneal opacity that would interfere with the laser beam. * Presence of blood or other material in the anterior chamber. * Hypotony or presence of corneal implant. * Poorly dilating pupils. * Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium. * Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality. * Any contraindication to cataract surgery. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Capsular Tears (Anterior or Posterior) During Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Time in the Eye to Complete Entire Cataract Procedure | 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. |
Participant flow
Recruitment details
Subjects were recruited from 14 investigative sites: 1 located in Greece, 4 located in India, 2 located in Mexico, 1 located in the Philippines, 3 located in Romania, and 3 located in the US.
Pre-assignment details
Of the 406 enrolled, 6 subjects were exited as screen failures and 10 withdrew prior to randomization. This reporting group includes all randomized subjects (390).
Participants by arm
| Arm | Count |
|---|---|
| Laser (LSX) Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery | 187 |
| Manual (CCC) CCC performed during cataract surgery | 189 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Reason not given | 2 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Laser (LSX) | Manual (CCC) | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 13.6 | 66.4 years STANDARD_DEVIATION 11.9 | 65.6 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 110 Participants | 117 Participants | 227 Participants |
| Sex: Female, Male Male | 77 Participants | 72 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 406 | 0 / 188 | 0 / 191 |
| other Total, other adverse events | 0 / 406 | 46 / 188 | 43 / 191 |
| serious Total, serious adverse events | 1 / 406 | 16 / 188 | 14 / 191 |
Outcome results
Primary
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
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.
Time frame: Day 0 (operative day)
Population: Intent-to-Treat Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser (LSX) | Percentage of Capsular Tears (Anterior or Posterior) During Surgery | 5.3 percentage of capsular tears |
| Manual (CCC) | Percentage of Capsular Tears (Anterior or Posterior) During Surgery | 5.3 percentage of capsular tears |
Secondary
Operating Time in the Eye to Complete Entire Cataract Procedure
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.
Time frame: Day 0 (operative day)
Population: Intent-to-Treat Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser (LSX) | Operating Time in the Eye to Complete Entire Cataract Procedure | 795.0 seconds | Standard Deviation 354.7 |
| Manual (CCC) | Operating Time in the Eye to Complete Entire Cataract Procedure | 856.6 seconds | Standard Deviation 436.3 |