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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04952181
Collaborator
(none)
40
2
7.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: optical biometry
  • Device: ultrasonic biometry
N/A

Detailed Description

  • Prospective interventional (QUASI experimental) comparative study

  • This study will be conducted on high myopic cataractous patients scheduled for phacoemulsification and IOL implantation in department of ophthalmology, Sohag university

  • patients will be divided into 2 groups one will be subjected to intraocular lens (IOL) calculation by optical biometry the second one will be subjected to intraocular lens (IOL) calculation by ultrasonic biometry

  • postoperative auto refraction after I month

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Optical Biometry Versus Ultrasonic Biometry in Intraocular Lens Calculation in High Myopic Cataractous Patients: A Comparative Study
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: optical biometry

Device: optical biometry
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.

Experimental: ultrasonic biometry

Device: ultrasonic biometry
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

Outcome Measures

Primary Outcome Measures

  1. desired post operative refraction [postoperative refraction 1 month]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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
Exclusion Criteria:
  1. History of trauma

  2. Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy

  3. corneal opacities or irregularities, scars, dystrophy or ectasia

  4. Patients who underwent previous corneal surgery (including refractive surgery)

  5. 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Esraa Ahmed Okasha, principle investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT04952181
Other Study ID Numbers:
  • Soh-Med-21-06-01
First Posted:
Jul 7, 2021
Last Update Posted:
Jul 7, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2021