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临床试验/CTRI/2025/09/095005
CTRI/2025/09/095005尚未招募不适用

Analysis of prevalence of corneal biomechanical changes post squint study in age group of 12-40 years

Sankara Eye Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
Changes in corneal biomechanics using Corvis ST parameters:

研究概览

简要总结

Title :  Analysis of prevalence of corneal biochemical changes in post squint surgeries in patients with age group of 12-40 years.

Squint, also called crossed eyes, is a condition where the two eyes do not point in the same direction. This can affect a person’s appearance, confidence, and sometimes even their ability to see clearly with both eyes together. Surgery to correct squint is commonly done in both children and adults to improve eye alignment, vision, and quality of life.

The front part of the eye, called the cornea, is like the clear window through which we see. It not only lets light into the eye but also has to stay strong and maintain its shape for clear vision. Now we have advanced tools like the Corvis ST, which use a gentle puff of air and a special camera to measure how flexible or strong the cornea is. These measurements can tell us if surgery affects the eye’s structure and whether those effects are temporary or long-lasting.

Study Purpose:

This is a prospective cohort study will be conducted from August 2025 to July 2026,enrolling 42 patients with squint .

This study will check if squint surgery causes any changes in the strength or flexibility of the eye in people aged 12 to 40 years. We will use the Corvis ST machine to measure these changes before surgery, and again at 1 month and 3 months after surgery.

We will record information about each patient and measure the eye’s strength before surgery.

Perform squint surgery using standard procedures.

Repeat the eye strength test at 1 month and 3 months after surgery.

Compare results based on the type of surgery, number of muscles operated, and type of incision used.

The Primary Objective is to check if squint surgery causes any changes in the strength and flexibility of the front part of the eye (cornea) using the Corvis ST machine before surgery, and again at 1 month and 3 months after surgery

While Secondary Objectives are -To compare changes based on the type of surgery

-To see if changes differ when one or more muscles are operated.

-To check if the type of cut made during surgery (limbal vs forniceal) affects the results.

-To find out whether the changes are temporary or long-term.

-To see if changes in the cornea relate to any changes in eyesight after surgery.

Expected results-

We expect to find temporary changes in corneal strength and flexibility after surgery that should return close to normal within 3 months.

Or does type of surgery or incision or number of muscles operated has any effects on outcome of surgery- in turn on postoperative vision.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients between age group of 12-40 years posted for squint surgery.

排除标准

  • Patients or parents not willing.
  • Any neurological abnormalities like cerebral palsy or mental retardation.
  • Any Prior ocular surgeries.
  • Transposition procedures done in the eye.
  • Restrictive strabismus.

结局指标

主要结局

Changes in corneal biomechanics using Corvis ST parameters:

时间窗: Baseline preoperative, Postoperative 1 month and 3 months.

CBI (Corvis biochemical Index)

时间窗: Baseline preoperative, Postoperative 1 month and 3 months.

TBI (Tomographic Biomechanical Index)

时间窗: Baseline preoperative, Postoperative 1 month and 3 months.

Transient corvis changes expected to normalize within 3 months of surgery

时间窗: Baseline preoperative, Postoperative 1 month and 3 months.

次要结局

  • Influence of procedure type (recession, resection, or combined) on the magnitude of corneal biomechanical changes.(Assessment of the biomechanical changes in :)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dhanshree Rathod

Sankara Eye Hospital

研究点 (1)

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