Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients

NCT04952181 | Unknown

• 1 other identifier: Soh-Med-21-06-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

the purpose of the study is to compare the accuracy of optical and ultrasonic biometry in intraocular lens (IOL) calculation in high myopic cataractous patients

Conditions

Calculation of Intraocular Lens in High Myopic Cataractous Patients

Outcome Measures

Primary Outcomes (1)

• desired post operative refraction

  detection of postoperative refraction by the use of autorefractor (one of the objective methods of assessment of refraction) after use of IOL power calculated by different investigations (optical vs ultrasonic)

  postoperative refraction 1 month

Study Arms (2)

optical biometry

EXPERIMENTAL

Device: optical biometry

ultrasonic biometry

EXPERIMENTAL

Device: ultrasonic biometry

Interventions

optical biometry DEVICE

optical biometry is a fast, noncontact method it uses the method of partial coherence interferometry (PCI) to measure the axial length (AXL), based on reflection of the interference signal of the retinal pigment epithelium.

optical biometry

ultrasonic biometry DEVICE

ultrasonic biometry is contact method depends on ultrasonic transducer producing thin sound beam travelling through different media of the eye when it faces interface of substance dissimilar from that it is travelling through part is reflecting and the other travel through the different substance

ultrasonic biometry

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry IOL implantation With axial length (AXL) equal to or greater than 26.5mm

You may not qualify if:

• History of trauma
• Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy
• corneal opacities or irregularities, scars, dystrophy or ectasia
• Patients who underwent previous corneal surgery (including refractive surgery)
• Patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the IOL (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• Tappeiner C, Rohrer K, Frueh BE, Waelti R, Goldblum D. Clinical comparison of biometry using the non-contact optical low coherence reflectometer (Lenstar LS 900) and contact ultrasound biometer (Tomey AL-3000) in cataract eyes. Br J Ophthalmol. 2010 May;94(5):666-7. doi: 10.1136/bjo.2009.167700. No abstract available.

  PMID: 20447976 BACKGROUND

• Wang L, Shirayama M, Ma XJ, Kohnen T, Koch DD. Optimizing intraocular lens power calculations in eyes with axial lengths above 25.0 mm. J Cataract Refract Surg. 2011 Nov;37(11):2018-27. doi: 10.1016/j.jcrs.2011.05.042.

  PMID: 22018365 BACKGROUND

• Olsen T. Improved accuracy of intraocular lens power calculation with the Zeiss IOLMaster. Acta Ophthalmol Scand. 2007 Feb;85(1):84-7. doi: 10.1111/j.1600-0420.2006.00774.x.

  PMID: 17244216 BACKGROUND

Central Study Contacts

Esraa A Okasha, Resident

CONTACT

01028909988; esraa011037@med.sohag.edu.eg

Usama A Mohamed, Professor

CONTACT

01005470455

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: July 7, 2021

Record last verified: 2021-06