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临床试验/CTRI/2026/01/102200
CTRI/2026/01/102200尚未招募不适用

analysing bleb morphology after trabeculectomy using anterior segment Optical Coherence Tomography

Nethradhama Super Speciality Eye Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

MethodologyThis prospective observational and descriptive study will be approved by the Institutional Ethics Committee of Nethradhama Eye Hospital and will adhere to the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.

Surgical ProcedureFollowing creation of a fornix based conjunctival flap a sponge soaked in Mitomycin C at a concentration of two hundred micrograms was applied under the conjunctiva for a duration of two minutes taking care that the Mitomycin C soaked sponge did not come in contact with the edge of the conjunctival flap. A partial thickness rectangular scleral flap was created followed by creation of a sclerostomy measuring two by two millimeters using scissors or Kelly punch. Closure of the scleral flap was performed using two side permanent sutures and one apical releasable ten zero nylon suture. The conjunctiva was closed using ten zero nylon sutures. Postoperatively antibiotic and steroid eye drops were administered in a tapering dose over a period of two months.

Imaging and Evaluation of Filtering BlebAll blebs will be imaged using slit lamp photography under standardized illumination and magnification settings. All blebs will also be imaged using anterior segment optical coherence tomography using the Cirrus HD OCT five hundred system manufactured by Carl Zeiss Dublin California United States using a standardized imaging protocol.

Optical coherence tomography is a high resolution tomographic and biomicroscopic imaging device designed for anterior segment imaging and measurement with an axial resolution of eighteen micrometers. The principle of imaging is based on low coherence interferometry using a thirteen hundred ten nanometer superluminescent light emitting diode. Similar to an ultrasound B scan the Cirrus OCT acquires multiple A scans and aligns them to construct two dimensional images.

Patients will be instructed to look downward and the upper eyelid will be gently elevated to expose the bleb adequately while ensuring that no pressure is exerted on the globe or the bleb. Two scans namely radial and tangential will be obtained through the point of maximum bleb elevation.

Assessment ParametersAnterior segment optical coherence tomography images will be evaluated by a single trained observer who will be masked to the clinical data. Blebs will be assessed qualitatively for bleb height bleb wall thickness in millimeters bleb wall reflectivity categorized as low medium or high and bleb pattern classified as uniform or multiform. Scleral flap configuration measured in millimeters will also be evaluated. Additional features assessed include the scleral flap morphology and the route of aqueous flow beneath the scleral flap.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 84.00 Year(s)(—)
性别
All

入选标准

  • Post-trabeculectomy patients with primary glaucoma (open angle/angle closure) underwent surgery when-uncontrolled on maximal medical treatment.
  • Baseline IOP was considered as an average of minimum two measurements, atleast two weeks apart.
  • They were measured during different times of the day.

排除标准

  • Patients with significant conjunctival scarring,ocular surface disease affecting imaging ,secondary glaucoma and congenital glaucoma.

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

DrSamra wahaj Fatima

Nethradhama Super Speciality Eye Hospital

研究点 (1)

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