Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan
Peshawar, KPK, 25000, Pakistan
NCT Number: NCT07735000
This randomized controlled trial evaluated the effect of trypan blue on corneal endothelial cell count in patients undergoing phacoemulsification for age-related cataract. Sixty participants were randomly assigned to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. The primary objective was to compare postoperative corneal endothelial cell count between the two groups using specular microscopy to determine whether trypan blue has an effect on corneal endothelial cell loss during cataract surgery.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Peshawar, KPK, 25000, Pakistan
Age-related cataract is one of the leading causes of reversible visual impairment worldwide. Trypan blue is commonly used during phacoemulsification to stain the anterior lens capsule, particularly in mature or dense cataracts, to facilitate continuous curvilinear capsulorhexis. Although trypan blue improves intraoperative visualization, concerns remain regarding its potential effect on the corneal endothelium.
This single-center, parallel-group, randomized controlled trial was conducted at the Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan. Sixty patients aged 45 to 75 years with age-related cataract scheduled for phacoemulsification were randomly allocated in a 1:1 ratio to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. All procedures were performed using a standardized surgical technique by the same surgical team.
The primary outcome was postoperative corneal endothelial cell count measured by specular microscopy. The study compared postoperative endothelial cell counts and endothelial cell loss between the two treatment groups to evaluate the effect of trypan blue on corneal endothelial safety during phacoemulsification.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trypan blue was administered intracamerally to stain the anterior lens capsule before continuous curvilinear capsulorhexis during phacoemulsification. The dye was removed after adequate staining, and the remaining surgical procedure was completed using the standard technique.
Standard phacoemulsification with posterior chamber intraocular lens implantation performed using a standardized surgical technique
Time frame: At 4 weeks after surgery
Corneal endothelial cell density was measured by specular microscopy and reported as cells/mm². The mean postoperative endothelial cell count was compared between the trypan blue group and the control group.
Time frame: At 4 weeks after surgery
Corneal endothelial cell density was measured by specular microscopy and reported as cells/mm². The mean postoperative endothelial cell count was compared between participants undergoing phacoemulsification with trypan blue and those undergoing phacoemulsification without trypan blue.
Hayat Abad Medical Complex, Peshawar
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