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To study the success rate of evisceration with Hydroxyapatite orbital implant compared with Polymethylmethacrylate orbital implant

A Randomized Controlled Trial on Outcomes of Polymethylmethacrylate and Hydroxyapatite Implants in Evisceration: Introducing the Four-Petal Myoconjunctival Technique

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251102007
Enrollment
40
Registered
2025-11-02
Start date
2019-03-07
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

Patients over 15 years of age undergoing evisceration with myoconjunctival technique evisceration, myoconjunctival technique, Polymethylmethacrylate, Hydroxyapatite orbital implants, orbital implant motility , prosthetic motility

Interventions

Evisceration with four-petal scleral wrapped PMMA ( Polymethylmethacrylate ) orbital implant using myoconjunctival technique,Evisceration with four-petal scleral wrapped HA ( Hydroxyapatite ) orbital
Experimental Procedure/Surgery,Experimental Procedure/Surgery
PMMA orbital implant,HA orbital implant

Sponsors

The Health Systems Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients over 15 years of age 2. untreatable severe corneal ulcer 3. untreatable endophthalmitis 4. panophthalmitis 5. painful or nonfunctional eye, 6. phthisis bulbi

Exclusion criteria

Exclusion criteria: 1. complex underlying diseases precluding general anesthesia 2. severe orbital fractures affecting orbital volume 3. severe orbital trauma causing significant conjunctival or extraocular muscle injury 4. intra-orbital tumors

Design outcomes

Primary

MeasureTime frame
Success rate of evisceration 8 weeks postoperatively Proportion of cases with complete healing without postoperative complications (e.g., implant exposure, extrusion, infection)

Secondary

MeasureTime frame
Post-operative complications and orbital implant and prosthetic motility until last visits for postoperative complications and at 2 weeks postoperatively and last visits fot impant and prosthetic motility Proportions of cases with posterative complications and for implant and prosthetic motility were measured for 4 directions ( up, down , adduction , and abduction ) in millimeters

Countries

Thailand

Contacts

Public ContactSuppapong Tirakunwichcha

Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

suppapong@gmail.com6622564000

Outcome results

None listed

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