Mydriatic Drops After Combined Surgery

Rabin Medical Center (Other)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

The study goal is to evaluate the influence of mydriatic drops on the development of posterior synechia after combined cataract and vitrectomy surgery.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cyclopentolate Hydrochloride 1.0% eye drops

Detailed Description

Cataract and vitreoretinal disorders often coexist, and with up to 80 percent chance for cataract formation following vitreoretinal surgery within the first year, combined surgery of phacoemulsification, pars plana vitrectomy (PPV) and intraocular lens (IOL) implantation has become increasingly accepted.

The main advantages of combined surgery include better visualization during surgery and the elimination of the need for additional surgery, which translates to overall quicker visual recovery and cost-effectiveness. Like the more exercised, two-step procedure, the combined surgery was shown to be safe and effective with relatively few complications. However, one complication seen more frequently after the combined surgery is postoperative anterior chamber inflammatory response, and with it, the formation of posterior synechia, reaching an average of 18 percent.

The development of posterior synechia interferes with postoperative visualization of the fundus, thus diminishing an important advantage of the combined procedure. Moreover, in a few cases, it can even be complicated by angle closure glaucoma.

Currently, there is no consensus on whether postoperative treatment after combined surgery should include additional treatment to help prevent the formation of synechia. The frequency and severity of posterior synechia after a combined operation may be reduced using short-acting mydriatics. However, there is no sufficient data nor a prospective study to support this as common practice. It is, therefore, we sought to better evaluate the effect of topical short-acting mydriatics on the formation of posterior synechia after combined surgery and compare it with standard postoperative treatment.

Study Design

Study Type:
Actual Enrollment :
60 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
The Effect of Mydriatics on Posterior Synechia After Combined Surgery of Pars Plana Vitrectomy, Phacoemulsification, and Intraocular Lens Implantation
Actual Study Start Date :
Nov 10, 2020
Actual Primary Completion Date :
Jan 3, 2022
Actual Study Completion Date :
Jan 3, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Control group receives standard post-operative treatment, which includes self-instillation of Ofloxacin and Dexamethasone eye drops with tapering down from q.i.d for the 1st week to once daily in the 4th week

Experimental: Study

The study group receives standard post-operative treatment same as the control group. And additional treatment of a short-acting mydriatic agent (Cyclopentolate Hydrochloride 1.0% eye drops) t.i.d for 4 weeks (to operate eye alone)

Drug: Cyclopentolate Hydrochloride 1.0% eye drops
A short-acting mydriatic agent

Outcome Measures

Primary Outcome Measures

  1. Number of participants developed iris posterior synechiae after surgery [24 weeks]

    Iris posterior synechia is an adhesion formed between the iris and the capsular bag, which holds the implanted lens in place. It is a relatively common complication observed after intra-ocular surgery. Viewed under the slit lamp at the standard ophthalmologist examination after surgery. Mild to Moderate synechia can interrupt pupil dilatation and interfere with postoperative visualization of the fundus, thus diminishing an advantage of the combined surgery. Substantial synechia may affect the movement of the aqueous from the posterior to the anterior chamber resulting in secondary angle closure glaucoma.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Patients who underwent combined cataract and vitrectomy surgery with IOL implantation.
Exclusion Criteria:
  • History of uveitis prior to surgery.

Contacts and Locations


Site City State Country Postal Code
1 Rabin Medical Center Petah Tikva Israel 4941492

Sponsors and Collaborators

  • Rabin Medical Center


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Yair Pesoa, Dr, Principal Investigator., Rabin Medical Center Identifier:
Other Study ID Numbers:
  • 0243-20-RMC
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022