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

NCT ID: NCT04334473

Last Updated: 2020-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucoma Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants are assigned to the same interventions. All will undergo pre- \& postoperative assessment, cataract surgery.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cataract patients

Patients having cataract candidates for phacoemulsification with or without glaucoma are prepared to do cataract surgery with preoperative and postoperative assessment of intraocular pressure and ocular bio-metrics using UBM.

Group Type OTHER

phacoemulsification and Intraocular lens implantation

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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phacoemulsification and Intraocular lens implantation

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.

Intervention Type PROCEDURE

Ultrasound Biomicrosopy (UBM)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mai Nasser Abd Elmohsen

OTHER

Sponsor Role lead

Responsible Party

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Mai Nasser Abd Elmohsen

Lecturer of ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karim A Raafat, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of medicine, Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Elgin U, Sen E, Simsek T, Tekin K, Yilmazbas P. Early Postoperative Effects of Cataract Surgery on Anterior Segment Parameters in Primary Open-Angle Glaucoma and Pseudoexfoliation Glaucoma. Turk J Ophthalmol. 2016 Jun;46(3):95-98. doi: 10.4274/tjo.92604. Epub 2016 Jun 6.

Reference Type BACKGROUND
PMID: 27800269 (View on PubMed)

Melancia D, Abegao Pinto L, Marques-Neves C. Cataract surgery and intraocular pressure. Ophthalmic Res. 2015;53(3):141-8. doi: 10.1159/000377635. Epub 2015 Mar 7.

Reference Type RESULT
PMID: 25765255 (View on PubMed)

Hsu CH, Kakigi CL, Lin SC, Wang YH, Porco T, Lin SC. Lens Position Parameters as Predictors of Intraocular Pressure Reduction After Cataract Surgery in Nonglaucomatous Patients With Open Angles. Invest Ophthalmol Vis Sci. 2015 Dec 1;56(13):7807-7813. doi: 10.1167/iovs.15-17926.

Reference Type RESULT
PMID: 26650901 (View on PubMed)

Man X, Chan NC, Baig N, Kwong YY, Leung DY, Li FC, Tham CC. Anatomical effects of clear lens extraction by phacoemulsification versus trabeculectomy on anterior chamber drainage angle in primary angle-closure glaucoma (PACG) patients. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):773-8. doi: 10.1007/s00417-015-2936-z. Epub 2015 Feb 3.

Reference Type RESULT
PMID: 25644619 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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N-45-2019

Identifier Type: -

Identifier Source: org_study_id

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