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Randomized double-masked comparative study of intraocular pressure and wound status between eyes immediately after scleral tunnel incision and clear corneal incision cataract surgery

Randomized double-masked comparative study of intraocular pressure and wound status between eyes immediately after scleral tunnel incision and clear corneal incision cataract surgery - Intraocular pressure and wound status in eyes immediately after scleral tunnel and clear corneal incision cataract surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013526
Enrollment
64
Registered
2014-03-27
Start date
2013-05-10
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 scleral tunnel incision with 2.4 mm in length in unilateral eyes of 64 enrolled patients Phacoemulsification surgery using clear corneal incision with 2.4 mm in lengt

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 10, 2013. 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 scleral tunnel incision cataract surgery 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 scleral tunnel incision cataract surgery 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
1) Longitudinal changes in intraocular pressure (IOP) using rebound tonometer after cataract surgery preoperatively, at the conclusion of surgery; and at 5, 10, 15, 30, and 60 minutes postoperatively. 2) Wound structure at 30 minutes postoperatively using the anterior segment-optical coherence tomography (AS-OCT)

Secondary

MeasureTime frame
3) Wound leakage at 30 minutes after surgery examined using the Seidel test 4) Flare intensity at 45 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