Comparison of posterior capsule opacification after two different surgical methods of cataract extraction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88815601

Enrollment

Registered

2007-10-22

Start date

2004-11-11

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Cataracts Eye Diseases Other cataract

Interventions

The AquaLase is used in the right eye and NeoSoniX in the left eye of each patient. The same IOL (Alcon AcrySof® Single Piece Intraocular Lens) is implanted in all eyes. Examination is carried out a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Bilateral non-brunescent cataract (according to the Buratto classification - a cataract grade less than 5) 2. Both eyes with cataract with similar density grade 3. No other severe ocular pathology potentially affecting visual acuity (patients with mild age-related macular degeneration [ARMD] were not excluded) 4. Age 40 or older 5. Both males and females 6. Written informed consent to surgery and willing to participate in the study 7. Good compliance

Exclusion criteria

Exclusion criteria: 1. Brunescent cataract 2. Severe ocular pathology potentially affecting visual acuity 3. Unable to achieve good artificial mydriasis 4. No informed consent

Design outcomes

Primary

Measure	Time frame
The following will be measured at 1, 2, 3 and 5 years after surgery: 1. EPCO index for minimal, mild, moderate and severe opacities and total EPCO index for PCO under entire IOL optic (score 0 = no opacities, 4 = maximal opacities) 2. OSCA score. The possible range is from 0 (no PCO) to approximately 15 (practical expected maximum). Typical OSCA values for images with very little or no PCO is around 0.5. Values for patients that are deemed to warrant laser capsulotomy is typically around 4 - 5. 3. Best corrected visual acuity measured using Snellen optotypes at 6 metres distance	—

Measure

Time frame

The following will be measured at 1, 2, 3 and 5 years after surgery: 1. EPCO index for minimal, mild, moderate and severe opacities and total EPCO index for PCO under entire IOL optic (score 0 = no opacities, 4 = maximal opacities) 2. OSCA score. The possible range is from 0 (no PCO) to approximately 15 (practical expected maximum). Typical OSCA values for images with very little or no PCO is around 0.5. Values for patients that are deemed to warrant laser capsulotomy is typically around 4 - 5. 3. Best corrected visual acuity measured using Snellen optotypes at 6 metres distance

—

Secondary

Measure	Time frame
The "Nd:YAG" laser capsulotomy rate at 1, 2, 3 and 5 years after surgery. This shows how many capsulotomies are needed for treatment of PCO-induced decrease of BCVA.	—

Countries

Czech Republic

Outcome results

None listed

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