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Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision.

Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision. - Intraocular pressure (IOP) and wound architectures in eyes immediately after long and short clear corneal incision cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030513
Enrollment
128
Registered
2017-12-22
Start date
2017-08-04
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Cataract

Interventions

64 eyes of 64 patients are scheduled to undergo long-length temporal CCI (more than 1.75 mm). 64 eyes of 64 patients are scheduled to undergo short-length temporal CCI (less than 1.75 mm).

Sponsors

Hayashi Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study was an exploratory study to compare the IOP and wound architectures between eyes with long CCI and eyes with short CCI, conducted between January and December, 2017 at the Hayashi Eye Hospital. A clinical research coordinator screened all consecutive patients scheduled for admitting the Hayashi Eye Hospital to undergo bilateral phacoemulsification and implantation of a single-piece acrylic intraocular lens (IOL).

Exclusion criteria

Exclusion criteria: eyes with any pathology of the cornea, macula, and optic nerve; eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III;14 eyes with a possible zonular dehiscence, a history of ocular inflammation or surgery; eyes with poor mydriasis smaller than 4.5 mm; patient refusal; and any anticipated difficulties with examination

Design outcomes

Primary

MeasureTime frame
1) Longitudinal changes in intraocular pressure (IOP) using rebound tonometer before surgery, at the end of surgery (adjusted in a range between 15 and 25 mmHg); and at 30, 60, 120, 180 minutes, and 24 hours after surgery 2) Wound architectural features and wound length at 60 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT)

Secondary

MeasureTime frame
3) Wound leakage at 60 minutes after surgery examined using the Seidel test 4) Flare intensity at 60 minutes after surgery determined using the flare meter

Countries

Japan

Contacts

Public ContactKen Hayashi

Hayashi Eye Hospital Department of Ophthalmology

hayashi-ken@hayashi.or.jp092-431-1680

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026