Age Related Cataract, Cataract
Conditions
Keywords
Phacoemulsification, Trypan blue, Cataract Surgery, Corneal Endothelium, Endothelial Cell Count, Specular Microscopy
Brief summary
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.
Detailed description
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.
Interventions
DRUGTrypan Blue
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.
PROCEDUREPhacoemulcification
Standard phacoemulsification with posterior chamber intraocular lens implantation performed using a standardized surgical technique
Sponsors
Hayat Abad Medical Complex, Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. Group A underwent phacoemulsification with trypan blue staining of the anterior capsule, while Group B underwent the same procedure without trypan blue. Each participant remained in the assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 45 to 75 years. * Diagnosed with age-related cataract. * Scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation. * Able and willing to provide written informed consent.
Exclusion criteria
* Diabetes mellitus. * Glaucoma. * Previous ocular surgery. * Corneal opacity. * Pre-existing corneal endothelial disease. * Uveitis. * Traumatic cataract. * Complicated cataract. * Any other ocular pathology that could affect corneal endothelial cell count or interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Corneal Endothelial Cell Count | 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. |
Countries
Pakistan
Outcome results
None listed