AIM:To compare the exposure rate,infection rate,percentage of enhancement,and success rate between Medpor and the three-dimensional printed polyethylene(3DP-PE)orbital implant in a preliminary report.METHODS:This pros...AIM:To compare the exposure rate,infection rate,percentage of enhancement,and success rate between Medpor and the three-dimensional printed polyethylene(3DP-PE)orbital implant in a preliminary report.METHODS:This prospective,randomized,equivalence,controlled trial was conducted at two institutes.The equivalent margin was±10%.The sample size for the equivalence trial was 174 participants per group.Patients who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of six.The surgeries were performed by five oculoplastic surgeons.The assessor and patients were masked.The magnetic resonance imaging(MRI)of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J software.Follow-up continued at least 1y after surgery.The intention to treat and per protocol approaches were used.RESULTS:Totally 128 patients met the criteria in the report.Fifty Medpor and 553DP-PE cases completed the trial.The most common cause of blindness was trauma.The mean follow-up times of Medpor and 3DP-PE were 33 and 40mo respectively.The exposure rate was not statistically significant between two groups(6.0%and 7.3%),P<0.05,95%CI(-9.8%,+12.0%).The success rates were 94%(Medpor)and 92.7%(3DP-PE).No postoperative infection was reported.Nine patients had MRI tests and two had implant exposures with 66.3%enhancement at 75mo(Medpor)and 58%enhancement at 57mo(3DP-PE)postoperatively.CONCLUSION:There is no statistically significant difference in exposure rate and success rate between Medpor and 3DP-PE in enucleation in the report.However,we cannot conclude that they are equivalent in terms of the exposure rate and success rate because the 95%CI is wider than±10%.The infection rate is equivalent in both groups.展开更多
Rationale:Primary adenocarcinoma of the lacrimal gland is rare,and its presentation as corneal perforation is even rarer.Corneal perforation is an ocular emergency that warrants urgent ophthalmic surgery,yet complete ...Rationale:Primary adenocarcinoma of the lacrimal gland is rare,and its presentation as corneal perforation is even rarer.Corneal perforation is an ocular emergency that warrants urgent ophthalmic surgery,yet complete staging of lacrimal gland tumor pre-operatively is essential for optimal oncological management.Patient's concerns:A 57-year-old man presented with left eye pain was found to have left eye proptosis and fleshy tissue mass around the eyeball.Uveal tissue was prolapsing over the perforated keratitis cornea,and the eye was full of discharge.Diagnosis:Bedside ultrasound B-scan confirmed vitreous haze,and emergency contrast computed tomography(CT)revealed soft tissue density mass(>40 mm)molding around the left globe and optic nerve without any rim enhancing abscess.Left exogenous endophthalmitis from exposure keratopathy secondary to proptosis caused by the bulky lacrimal tumor located in the confined orbital cone was diagnosed.Interventions:Emergency enucleation surgery of the left eyeball was done for this painful blind eye to control the infection from spreading.Orbital walls were biopsied intra-operatively,and tumor staging was completed by positron emission tomography-CT scan and magnetic resonance imaging.Without evidence of metastasis,left orbital exenteration was followed by adjuvant orbital chemoradiotherapy for the sake of close proximity of resection margin.Outcomes:Left exenterated orbit was fully epithelialized at around 2 months,and there was no recurrence of the disease up to present at the 1 year follow-up.Lessons:Thorough workup on the staging of the disease to minimize the number of operations for oncological patients is always a top priority,yet it may not always be possible as in our case presenting with corneal perforation.展开更多
基金Supported by the Mettapracharak grantThai Government Budget grant+1 种基金Health Systems Research Institute grantNational Science and Technology Development Agency grant.
文摘AIM:To compare the exposure rate,infection rate,percentage of enhancement,and success rate between Medpor and the three-dimensional printed polyethylene(3DP-PE)orbital implant in a preliminary report.METHODS:This prospective,randomized,equivalence,controlled trial was conducted at two institutes.The equivalent margin was±10%.The sample size for the equivalence trial was 174 participants per group.Patients who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of six.The surgeries were performed by five oculoplastic surgeons.The assessor and patients were masked.The magnetic resonance imaging(MRI)of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J software.Follow-up continued at least 1y after surgery.The intention to treat and per protocol approaches were used.RESULTS:Totally 128 patients met the criteria in the report.Fifty Medpor and 553DP-PE cases completed the trial.The most common cause of blindness was trauma.The mean follow-up times of Medpor and 3DP-PE were 33 and 40mo respectively.The exposure rate was not statistically significant between two groups(6.0%and 7.3%),P<0.05,95%CI(-9.8%,+12.0%).The success rates were 94%(Medpor)and 92.7%(3DP-PE).No postoperative infection was reported.Nine patients had MRI tests and two had implant exposures with 66.3%enhancement at 75mo(Medpor)and 58%enhancement at 57mo(3DP-PE)postoperatively.CONCLUSION:There is no statistically significant difference in exposure rate and success rate between Medpor and 3DP-PE in enucleation in the report.However,we cannot conclude that they are equivalent in terms of the exposure rate and success rate because the 95%CI is wider than±10%.The infection rate is equivalent in both groups.
文摘Rationale:Primary adenocarcinoma of the lacrimal gland is rare,and its presentation as corneal perforation is even rarer.Corneal perforation is an ocular emergency that warrants urgent ophthalmic surgery,yet complete staging of lacrimal gland tumor pre-operatively is essential for optimal oncological management.Patient's concerns:A 57-year-old man presented with left eye pain was found to have left eye proptosis and fleshy tissue mass around the eyeball.Uveal tissue was prolapsing over the perforated keratitis cornea,and the eye was full of discharge.Diagnosis:Bedside ultrasound B-scan confirmed vitreous haze,and emergency contrast computed tomography(CT)revealed soft tissue density mass(>40 mm)molding around the left globe and optic nerve without any rim enhancing abscess.Left exogenous endophthalmitis from exposure keratopathy secondary to proptosis caused by the bulky lacrimal tumor located in the confined orbital cone was diagnosed.Interventions:Emergency enucleation surgery of the left eyeball was done for this painful blind eye to control the infection from spreading.Orbital walls were biopsied intra-operatively,and tumor staging was completed by positron emission tomography-CT scan and magnetic resonance imaging.Without evidence of metastasis,left orbital exenteration was followed by adjuvant orbital chemoradiotherapy for the sake of close proximity of resection margin.Outcomes:Left exenterated orbit was fully epithelialized at around 2 months,and there was no recurrence of the disease up to present at the 1 year follow-up.Lessons:Thorough workup on the staging of the disease to minimize the number of operations for oncological patients is always a top priority,yet it may not always be possible as in our case presenting with corneal perforation.
