Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation

University of Campinas, Brazil

Status and phase: Completed; Phase 3

Conditions: Rhegmatogenous Retinal Detachment

Treatments: Procedure: criopexy; Procedure: laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01068379

cryo laser

Details and patient eligibility

About

The purpose of this randomized clinical trial was to compare reattachment rates among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Full description

The purpose of this randomized clinical trial was to compare reattachment rates, visual acuity results and epiretinal membrane formation among patients with rhegmatogenous retinal detachment who underwent scleral buckle surgery with retinopexy by cryotherapy versus postoperative (one month) laser photocoagulation.

Enrollment: 86 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary rhegmatogenous retinal detachment with a single peripherical retinal break. All patients were phakic, under eighteen years old, with partial posterior vitreous detachment, visual loss or symptoms (floaters and photopsia) less than 30 days

Exclusion criteria

• No patient had a retinal break greater than 30 degrees, or retinal detachment larger than two quadrants, history of uveitis or infectious retinopathy, presence of Proliferative vitreoretinopathy (B or C), macular disease, glaucoma, hemoglobinopathy, diabetic retinopathy, and history of trauma or previous vitreoretinal surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

86 participants in 2 patient groups

Cryopexy

Experimental group

Description:

the cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.

Treatment:

Procedure: criopexy

laser photocoagulation 4 weeks after

Experimental group

Description:

Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.

Treatment:

Procedure: laser