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Comparison of the Concordance Between Digital Marking and Manual Marking for Toric Intraocular Lens Positioning

2026년 7월 13일 업데이트: Pirapat Chareonboonsit, Thammasat University

Comparison of the Concordance Between Digital Image-Guided Navigation and Manual Peripheral Corneal Marking for Toric Intraocular Lens Positioning

This cross-sectional comparative study evaluated patients from a single cataract center. In each eye, manual horizontal meridian axis line was marked on the cornea using the manual peripheral corneal marking technique (Horizontal Slit Beam Marking ), while the Verion digital image-guided navigation system provided a reference axis fixed at the horizontal meridian (0°/180°). The primary outcome measure was the difference in degrees between the digital marker and the manual marker horizontal meridian as measured intraoperatively. Agreement was assessed using Bland-Altman analysis, reporting the mean bias (systematic error) and 95% limits of agreement (LoA, mean ± 1.96 SD). A misalignment of ±10° was defined as the threshold of clinical significance.

연구 개요

상태

아직 모집하지 않음

상세 설명

Patients with visually significant cataract and regular corneal astigmatism who were scheduled for phacoemulsification were screened for eligibility. Inclusion criteria were adults (18 -90 years of age) that were candidates for uncomplicated cataract surgery. The exclusion criteria were irregular corneal astigmatism, lens subluxation, uveitis, glaucoma, trauma, history of retinal disease or optic neuropathy, previous intraocular or corneal surgery and corneal disease that could not be evaluated by the ARGOS or VERION systems.

Preoperative assessment included best-corrected visual acuity (BCVA), which were determined by Snellen's chart and converted to logMAR. Spherical equivalent (SE) and astigmatic refraction (AR) were examined by Full Auto Ref-Keratometer (RK-F2, Canon). Evaluation for corneal astigmatism and axial length with ARGOS® Biometer. Slit lamp examination (BP 900®, Hagg-Streit) intraocular pressure measurement (Canon TX-20P), and dilated retinal examination was performed on all of the patients.

For manual technique a slit-lamp was used. Patients were seated with their head fixed with the horizontal supporting band and their chin placed in the center of the chinrest. A thin horizontal slit beam is projected onto the cornea and moved vertically (up and down) until the area of maximum light concentration (brightest reflection) on the corneal surface is identified. For each eye, after identifying the point of maximum light reflex, under topical anesthesia with 0.5% proparacaine hydrochloride eye drops, the corneal limbus was marked at the 0° and 180° meridian (3 and 9 o'clock) positions using a blunt tip of the Sinskey hook coated with sterile gentian violet ink, using light pressure as a single touch of approximately one second, in order to standardize ink deposition and minimize ink spread. The marking was maintained horizontally without any movement during the marking. The thickness of marks was routinely less than 0.25 mm

For the digital technique, preoperative biometry data obtained from the ARGOS Biometer were entered into the Alcon Vision Planner v1.6, which was paired with the VERION Image-Guided System (Alcon Laboratories, Inc., Fort Worth, Texas, USA) to project the digital overlays directly into the operating microscope. This module captures a high-resolution preoperative reference image of the eye which can be used to document the center of the undilated pupil, corneal reflex position or eccentricity of the visual axis, scleral vessels and iris structures. All marking was performed by the same experienced surgeon (W. Tattiyakul) who was experienced with using all techniques, performed all procedures and measurements. No complications had occurred.

With both the manual and digital marks visible intraoperatively, the angular deviation along the horizontal meridian (in degrees) between the manual mark and the digital reference was recorded from the operating-microscope display for each eye by two trained observers independently, each blinded to the other's readings, using the same standardized display. The mean of the two observers' readings was used for all subsequent analyses, and inter-observer agreement was assessed using the intraclass correlation coefficient (ICC) and Bland-Altman analysis

연구 유형

관찰

등록 (추정된)

100

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Cataract Patients at Thammasat University

설명

Inclusion Criteria:

  • candidates for uncomplicated cataract surgery

Exclusion Criteria:

  • irregular corneal astigmatism, lens subluxation, uveitis, glaucoma, trauma, history of retinal disease or optic neuropathy, previous intraocular or corneal surgery and corneal disease that could not be evaluated by the ARGOS or VERION systems

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean signed angular deviation in degrees of the manual slit-lamp horizontal reference mark from the VERION digital reference meridian
기간: 6 months
For each eye, the signed angular difference (degrees) between the horizontal reference meridian (0-180°) marked by the manual slit-lamp peripheral corneal marking technique and the corresponding meridian identified by the VERION Image-Guided System (reference standard) is measured intraoperatively. Clockwise deviation is coded positive and counterclockwise negative. Agreement is summarized across eyes as the mean signed angular deviation with 95% Bland-Altman limits of agreement. Reported in a single unit (degrees).
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of eyes within ±5° of the VERION digital reference meridian, measured intraoperatively
기간: 6 months
For each eye, the absolute angular difference (degrees) between the horizontal reference meridian marked by the manual slit-lamp peripheral corneal marking technique and the meridian identified by the VERION Image-Guided System (reference standard) is measured intraoperatively. The outcome is the proportion of eyes with an absolute deviation of 5° or less, reported as a percentage (%) of eyes assessed. ±5° is the pre-specified threshold of clinically acceptable agreement for the marking step.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 10일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2026년 10월 30일

연구 등록 날짜

최초 제출

2026년 7월 8일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • MTU-EC-OP-0-162/69

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Verion Digital Marking에 대한 임상 시험

3
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