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Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery

Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery - IOP and corneal shape between eyes with single-plane scleracorneal and corneal incision cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013909
Enrollment
64
Registered
2014-05-08
Start date
2013-12-06
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

Phacoemulsification surgery using transconjuctival single-plane sclerocorneal incision with 2.4 mm in length in unilateral eyes of 64 enrolled patients Phacoemulsification surgery using clear cornea

Sponsors

Hayashi Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All consecutive patients who were scheduled for bilateral cataract surgery at the Hayashi Eye Hospital from May 17, 2014. Bilateral eyes of 64 patients scheduled for cataract surgery were randomized to 1 of 2 groups: A) 32 patients who were to undergo a 2.4-mm single-plane sclerocorneal incision in the right eye and 2.4-mm clear corneal incision in the left eye, or B) 32 patients who were to undergo a 2.4-mm single-plane sclerocorneal incision in the left eye and 2.4-mm clear corneal incision in the right eye.

Exclusion criteria

Exclusion criteria: Exclusion criteria were eyes with any pathology of the cornea, vitreous body, macula, or optic nerve; eyes with glaucoma or ocular hypertension; eyes with pseudoexfoliation syndrome; eyes scheduled for planned extracapsular cataract extraction; a history of previous ocular surgery or inflammation; patients with diabetes; patient refusal; and any anticipated difficulties with examination or follow up.

Design outcomes

Primary

MeasureTime frame
A) Changes in IOP and wound structure immediately after cataract surrgery 1) Longitudinal changes in IOP using rebound tonometer after cataract surgery preoperatively, at the conclusion of surgery; and at 15, 30, 60, and 120 minutes, and 24 hours postoperatively. 2) Seidel test at 30 minutes postoperatively 3) Wound structure at 30 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT) B) Changes in corneal astigmatism and shape preoperatively and at 2, 14, 30, and 60 days postoperatively 4) Corneal astigmatism and surgically induced astigmatism determined using keratometer 5) Corneal shape change determined using corneal topography 5-1) Averaged difference map 5-2) Irregular corneal astigmatism determined by Fourier analysis

Secondary

MeasureTime frame
6) Corneal endothelial cell counts and central corneal thickness 7) Visual acuity 8) Refractive status (spherical power, refractive cylinder, manifest spherical equivalent power)

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