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Completed

NCT Number: NCT04334473

IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls

Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo university

Cairo, 11562, Egypt

About this study

All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth & lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle & lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- & postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40-70 years.
  • Glaucomtous and nonglaucomatous participants with visually significant cataracts.
  • Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
  • patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).

Exclusion criteria

  • Major intraoperative or postoperative complications from cataract surgery
  • Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
  • Uveitis, severe retinal diseases, or congenital Anomalies.
  • History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery

Treatment and study plan

phacoemulsification and intraocular lens implantation

Procedure

Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.

Ultrasound Biomicrosopy (UBM)

Diagnostic Test

A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.

Primary outcomes

  1. Intraocular pressure change

    Time frame: 4 weeks

    intraocular pressure measurement by Goldman's applanation tonometr

  2. ocular bio-metrics change

    Time frame: 4 weeks

    anterior chamber angle angle opening distance and anterior chamber depth change

Secondary outcomes

  1. Phacoemulsification as treatment to glaucoma

    Time frame: 4 weeks

    intraocular pressure decrease after surgery in glaucoma patients

Sponsors and collaborators

Lead sponsor

Mai Nasser Abd Elmohsen

Other

Registry information

Official study title

Intraocular Pressure and Ocular Biometrics Changes After Phacoemulsification in Glaucomatous Patients and Age Matched Controls, Comparative Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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