Pressure-Dependent Endothelial Outcomes in Cataract Surgery for Normal and Mildly Guttata Corneas: A Randomized Controlled Trial

A Double-Blind Randomized control Trial Study on Effect of IOP during Phacoemulsification Cataract Surgery between two groups- normal and low IOP- on Corneal Endothelial Cell Counts

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250316003

Enrollment

Registered

2025-03-16

Start date

2025-01-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Cataract petients with no or mild corneal guttata Corneal Endothelium Corneal Guttata Phacoemulsification Cataract Surgery Intraocular Pressure

Interventions

Intraocular pressure 55mmHg,Intraocular pressure 40mmHg

Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery

Normal intraocular pressure during phacoemulsification cataract surgery,Low intraocular pressure during phacoemulsification cataract surgery

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1 Cataract patients with diagnosis of corneal guttata stage1-3 by specular microscopy 2 Normal central corneal thickness 3 Having plan of undergoing Phacoemulsification cataract surgery by Dr.Teeravee Hongyok

Exclusion criteria

Exclusion criteria: 1 Patients with abnormal endothelial cell from other causes, such as Iridocorneal Endothelial Syndrome (ICE) or Posterior Polymorphous Corneal Dystrophy (PPMD), in one or both eyes 2 Unable to undergo endothelial cell measurement using Specular microscopy, or unreliable results 3 Currently taking antiplatelet medications, such as Aspirin and Clopidogrel, or anticoagulants such as Warfarin, and unable to stop taking more than 5 days prior to surgery 4 poor cooperate patients during the examination or surgery 5 Incomplete follow-up for 3-month period

Design outcomes

Primary

Measure	Time frame
Endothelial cell count At 3 months after the surgery Cells/mm2	—

Secondary

Measure	Time frame
Best Correct Visual Acuity 1week, 1 month and 3 months after surgery -,Endothelial cell count At 1week and 1 month after surgery Cells/mm2,Pain score Immediately after the surgery and 1 day after the surgery -,Cumulative disperse energy At the end of the surgery -,Phacoemulsification Time At the end of the surgery Minutes,Presence of Macula Edema At 3 months after surgery -,Retinal ganglion cells 3 months after surgery -	—

Measure

Time frame

Best Correct Visual Acuity 1week, 1 month and 3 months after surgery -,Endothelial cell count At 1week and 1 month after surgery Cells/mm2,Pain score Immediately after the surgery and 1 day after the surgery -,Cumulative disperse energy At the end of the surgery -,Phacoemulsification Time At the end of the surgery Minutes,Presence of Macula Edema At 3 months after surgery -,Retinal ganglion cells 3 months after surgery -

—

Countries

Thailand

Contacts

Public ContactTeeravee Hongyok

Rajavithi Hospital

Teeravee.H@rsu.ac.th022062900

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026